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| Model Number UNKNOWN EEA |
| Device Problems
Loss of or Failure to Bond (1068); Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Fatigue (1849); Hematoma (1884); Hemorrhage/Bleeding (1888); Hyperplasia (1906); Hypoxia (1918); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Necrosis (1971); Pain (1994); Renal Failure (2041); Scar Tissue (2060); Sepsis (2067); Septic Shock (2068); Seroma (2069); Tachycardia (2095); Chills (2191); Hernia (2240); Peritonitis (2252); Ulcer (2274); Impaired Healing (2378); Numbness (2415); Neck Pain (2433); Respiratory Failure (2484); Organ Dehiscence (2502); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Fibrosis (3167); No Code Available (3191); Constipation (3274); Swollen Lymph Nodes/Glands (4432); Liver Failure (4492); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 04/07/2017 |
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Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, the patient underwent an elective reversal of a colostomy.During the procedure, the gia stapler did not fire all its staples.The two remaining ends of the patients colon were re-anastomosed using an eea stapler.While recovering, the patient began experiencing severe generalized abdominal pain and later went into sepsis.The patient was taken back into surgery six days post op to have an exploratory laparotomy with peritoneal washout, over-sewing of distal rectosigmoid and proximal end sigmoid colostomy.Dehiscence of the anastomosis was discovered.The patient has undergone additional surgical procedures related to the failed procedure.
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Manufacturer Narrative
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Additional information - age or date of birth.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, the patient underwent an elective reversal of colostomy.It was reported that during the vent the gia stapler did not fire all of its staples.The two remaining ends of the patient¿s colon were re-anastomosed using an eea stapler.After the event, the patient experienced focal surface erosion/ulceration, granulation tissue changes, inflammation, fluid collection in abdomen/pelvis abscess, nodularity noted throughout the omentum and mesentery, enterococcus faecalis, moderate gnr, distention of splenic capsule, lymphoid hyperplasia, swollen lymph nodes, , hemaglobin, generalized weakness in upper and lower extremities, stocking like numbness in both hands, changes in balance and coordination of lower extremities, fecal diversion, open wound, ventral hernia with partial protrusion of non-obstructed segment of colon, seroma, staphylococcus aureus, small air bubbles in abdomen, hematoma, infection, induration, diverticulosis, atelectasis, hypoxemia, mucus plugs, mucus mucopurulent, sepsis, anastomotic leak, septic shock with peritonitis, dehiscence of sigmoid anastomosis with fecal peritonitis, feculent green fluid encountered in pelvis/ subdiaphragmatic areas/gutter, acute postprocedural respiratory failure, acute/subacute hepatic failure without coma, metabolic encephalopathy, complications of digestive system, acute kidney failure, disorder of phosphorus metabolism, pain, adhesions, tachycardia, wound dehiscence, wound drainage, necrotic adipose tissue, pale, clammy, hypertensive, hypothermic, purulent drainage with strong odor, necrotic tissue, small bowel beaten up, bleeding from surgical site, abdominal pain, pulling sensation, tender bulge in midline of abdomen, fibrotic scar tissue, attenuated fascia, distention, fibrinous debris, abdominal discomfort, orange thin liquid leaking from abdomen, chills, lack of energy, abdominal nausea.Patient treatments included hospitalization, icu in stable but critical condtion, neo-synephrine for pressor support, mechanically ventilated/intubated, bronchoscopy, antibiotics, peritoneal washout, oversew distal rectosigmoid, mobilization of splenic flexure, proximal end sigmoid colostomy, skin loosely approximated to allow drainage, dobhoff in place for tube feedings, neo-synephrine discontinued, placement of pigtail drainage catheter, fluid aspirated, iv fluid resuscitation, central line and arterial line placements, foley catheter, sedation, pain management, physical therapy, serial ct scans, daily labs, wound care, tube feedings, advancement of diet, open colostomy reversal, abdominal wall reconstruction with primary repair of ventral hernias, diverting loop ileostomy, placement of temporary ureteral stents, took portion of the proximal rectum includingthe prior staple line, ileum severely retracted, stoma bridged using a piece of red rubber catheter, jp drain placement, wound care, occupational therapy, recreational therapy, open abdominal incision/drainage, debridement of anterior necrotic fat, wet-to-dry dressings, wound vac placement, debridement of necrotic tissue, wound care with medi-honey and aquacel, reduction of parastomal hernia, ileostomy closure, adhesiolysis, retracted fascia, small bowel resection, staples and scab removed in medical doctor office, repairof ventral incisional and stomal hernias via primary re-approximation of fascia followed by onlay mesh, excision of extensive anterior abdominal wall scar tissue and attenuated fascia, removal of all staples, pain medication, incision/drainage of seroma with repeat multilayer closure of the abdominal wound, fibrinous debris scooped out, and drainage catheter removed.
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Event Description
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According to the reporter, the patient underwent an elective reversal of colostomy.It was reported that during the vent the gia stapler did not fire all of its staples.The two remaining ends of the patient¿s colon were re-anastomosed using an eea stapler.After the event, the patient experienced focal surface erosion/ulceration, gastroesophageal reflux disease, neck pain, granulation tissue changes, inflammation, fluid collection in abdomen/pelvis abscess, nodularity noted throughout the omentum and mesentery, enterococcus faecalis, moderate gnr, distention of splenic capsule, lymphoid hyperplasia, swollen lymph nodes, , hemaglobin, generalized weakness in upper and lower extremities, stocking like numbness in both hands, changes in balance and coordination of lower extremities, fecal diversion, open wound, ventral hernia with partial protrusion of non-obstructed segment of colon, seroma, staphylococcus aureus, small air bubbles in abdomen, hematoma, infection, induration, diverticulosis, atelectasis, hypoxemia, mucus plugs, mucus mucopurulent, sepsis, anastomotic leak, septic shock with peritonitis, dehiscence of sigmoid anastomosis with fecal peritonitis, feculent green fluid encountered in pelvis/ subdiaphragmatic areas/gutter, acute postprocedural respiratory failure, acute/subacute hepatic failure without coma, metabolic encephalopathy, complications of digestive system, acute kidney failure, disorder of phosphorus met abolism, pain, adhesions, tachycardia, wound dehiscence, wound drainage, necrotic adipose tissue, pale, clammy, hypertensive, hypothermic, purulent drainage with strong odor, necrotic tissue, small bowel beaten up, bleeding from surgical site, abdominal pain, pulling sensation, tender bulge in midline of abdomen, fibrotic scar tissue, attenuated fascia, distention, fibrinous debris, abdominal discomfort, orange thin liquid leaking from abdomen, chills, lack of energy, abdominal nausea and constipation.Patient treatments included hospitalization, icu in stable but critical condtion, neo-synephrine for pressor support, mechanically ventilated/intubated, bronchoscopy, antibiotics, peritoneal washout, oversew distal rectosigmoid, mobilization of splenic flexure, proximal end sigmoid colostomy, skin loosely approximated to allow drainage, dobhoff in place for tube feedings, neo-synephrine discontinued, placement of pigtail drainage catheter, fluid aspirated, iv fluid resuscitation, central line and arterial line placements, foley catheter, sedation, pain management, physical therapy, serial ct scans, daily labs, wound care, tube feedings, advancement of diet, open colostomy reversal, abdominal wall reconstruction with primary repair of ventral hernias, diverting loop ileostomy, placement of temporary ureteral stents, took portion of the proximal rectum including the prior staple line, ileum severely retracted, stoma bridged using a piece of red rubber catheter, jp drain placement, wound care, occupational therapy, recreational therapy, open abdominal incision/drainage, debridement of anterior necrotic fat, wet-to-dry dressings, wound vac placement, debridement of necrotic tissue, wound care with medi-honey and aquacel, reduction of parastomal hernia, ileostomy closure, adhesiolysis, retracted fascia, small bowel resection, staples and scab removed in medical doctor office, repair of ventral incisional and stomal hernias via primary re-approximation of fascia followed by onlay mesh, excision of extensive anterior abdominal wall scar tissue and attenuated fascia, removal of all staples, pain medication, incision/drainage of seroma with repeat multilayer closure of the abdominal wound, fibrinous debris scooped out, and drainage catheter removed.Relevant tests/laboratory data: 07 apr 2017: pathology report from portion of sigmoid colon, colostomy reversal and anastomotic rings.Colostomy stoma showed focal surface erosion/ulceration, granulation tissue changes, associated acute and chronic inflammation.Anastomotic colonic rings showed patchy mild chronic inflammation.[rec uhc, 1271](b)(6)2017: labs abnormal for wbc 15.5 (b)(6)2017: ct scan revealed irregularly shaped fluid collection throughout left abdomen and pelvis, abscess measuring approximately 5cm in llq, free fluid present in ruq and scattered areas of free fluid with nodularity noted throughout the omentum and mesentery [cem10, 33] (b)(6)2017: abscess wound culture identified heavy enterococcus faecalis and moderate gnr.Labs abnormal for wbc 18.3, hemoglobin 10.7(b)(6) 2017: ct scan of abdomen and pelvis showed stable postsurgical change related to partial colectomy with diverting ostomy and placement of pigtail drainage catheter in llq.Fluid around pigtail catheter decreased in size, there is a persistent rim enhancing fluid collection above the drainage catheter measuring 10 cm which may communicate with the original drained pocket 13.3 cm rim enhancing fluid collection right abdomen adjacent to the tip of the right hepatic lobe concerning for 2nd abscess.Rim enhancing fluid surrounding the spleen/distending the splenic capsule also concerning for abscess [cem10, 30] (b)(6) 2018: pathology report from proximal rectal stump resection showed changes consistent prior anastomotic site, lymphoid hyperplasia suggestive of fecal diversion, and two reactive lymph nodes [rec un <(>&<)>c, 827] (b)(6)2018: ct scan of abdomen and pelvis showed no leak at the anastomosis, previously seen intra-abdominal fluid collections resolved.Rlq ileostomywith adjacent open packed abdominal wound.No drainable intra or extra abdominal fluid collection/abscess.[rec uh<(>&<)>c, 620] (b)(6)2018: per progress note, prior ct with rectal contrast showed no leak (b)(6) 2019: ct scan of abdomen and pelvis showed small supraumbilical ventral hernia with partial protrusion of a non-obstructed short segment of transverse colon (b)(6) 2019: abdominal wall seroma culture + for moderate growth staphylococcus aureus (b)(6) 2019: ct scan of abdomen and pelvis showed extra-abdominal subcutaneous well encapsulated fluid collection beginning from level of umbilicus continuing inferiorly to level of bladder.Measuring 9.8x25x20cm, containing multiple small air bubbles which may represent liquefying hematoma/seroma within the abdominal mesh.The air bubbles suggest a possible underlying infectious process as well.Mild induration of anterior subcutaneous tissues suggests mild inflammatory/reactive response.(b)(6) 2019, (b)(6)2019: ct scans of abdomen showed abdominal wall fluid collection most suggestive of an abscess, diverticulosis without evidence of diverticulitis (b)(6) 2019: ct scan of abdomen and pelvis showed collection within the subcutaneous tissues 15x4.1x10cm (b)(6) 2019: ct scan of abdomen and pelvis showed midline anterior abdominal collection anterior to rectus abdominal muscle within s ubcutaneous tissues which peripherally enhances and has multiple foci of air identified, findings suggestive of an abscess [med tfh 58] (b)(6)2019: ct scan of abdomen and pelvis showed resolving abdominal wall collection (b)(6)2019: ct scan of abdomen and pelvis showed improvement, persisting but resolving anterior wall collection (b)(6) 2019: ct scan of abdomen and pelvis showed anterior abdominal wall fluid collection/abscess is minimally increased, percutaneous drain in place (b)(6) 2019, (b)(6) 2019: ct scan of abdomen showed persisting but decreasing anterior abdominal wall collection (b)(6)2020: wound culture + for staph aureus heavy growth (b)(6) 2020: ct scan of abdomen and pelvis showed post-surgical changes within anterior abdomen, residual inflammatory change within subcutaneous soft tissues, and trace fluid/gas appear to have resolved.[med tfh, 53] (b)(6) 2021: abdominal wound culture + for heavy growth staphylococcus aureus a.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, the patient underwent an elective reversal of colostomy.It was reported that during the vent the gia stapler did not fire all of its staples.The two remaining ends of the patient¿s colon were re-anastomosed using an eea stapler.After the event, the patient experienced focal surface erosion/ulceration, granulation tissue changes, inflammation, fluid collection in abdomen/pelvis abscess, nodularity noted throughout the omentum and mesentery, enterococcus faecalis, moderate gnr, distention of splenic capsule, lymphoid hyperplasia, swollen lymph nodes, , hemaglobin, generalized weakness in upper and lower extremities, stocking like numbness in both hands, changes in balance and coordination of lower extremities, fecal diversion, open wound, ventral hernia with partial protrusion of non-obstructed segment of colon, seroma, staphylococcus aureus, small air bubbles in abdomen, hematoma, infection, induration, diverticulosis, atelectasis, hypoxemia, mucus plugs, mucus mucopurulent, sepsis, anastomotic leak, septic shock with peritonitis, dehiscence of sigmoid anastomosis with fecal peritonitis, feculent green fluid encountered in pelvis/ subdiaphragmatic areas/gutter, acute postprocedural respiratory failure, acute/subacute hepatic failure without coma, metabolic encephalopathy, complications of digestive system, acute kidney failure, disorder of phosphorus metabolism, pain, adhesions, tachycardia, wound dehiscence, wound drainage, necrotic adipose tissue, pale, clammy, hypertensive, hypothermic, purulent drainage with strong odor, necrotic tissue, small bowel beaten up, bleeding from surgical site, abdominal pain, pulling sensation, tender bulge in midline of abdomen, fibrotic scar tissue, attenuated fascia, distention, fibrinous debris, abdominal discomfort, orange thin liquid leaking from abdomen, chills, lack of energy, abdominal nausea and constipation.Patient treatments included hospitalization, icu in stable but critical condtion, neo-synephrine for pressor support, mechanically ventilated/intubated, bronchoscopy, antibiotics, peritoneal washout, oversew distal rectosigmoid, mobilization of splenic flexure, proximal end sigmoid colostomy, skin loosely approximated to allow drainage, dobhoff in place for tube feedings, neo-synephrine discontinued, placement of pigtail drainage catheter, fluid aspirated, iv fluid resuscitation, central line and arterial line placements, foley catheter, sedation, pain management, physical therapy, serial ct scans, daily labs, wound care, tube feedings, advancement of diet, open colostomy reversal, abdominal wall reconstruction with primary repair of ventral hernias, diverting loop ileostomy, placement of temporary ureteral stents, took portion of the proximal rectum including the prior staple line, ileum severely retracted, stoma bridged using a piece of red rubber catheter, jp drain placement, wound care, occupational therapy, recreational therapy, open abdominal incision/drainage, debridement of anterior necrotic fat, wet-to-dry dressings, wound vac placement, debridement of necrotic tissue, wound care with medi-honey and aquacel, reduction of parastomal hernia, ileostomy closure, adhesiolysis, retracted fascia, small bowel resection, staples and scab removed in medical doctor office, repair of ventral incisional and stomal hernias via primary re-approximation of fascia followed by onlay mesh, excision of extensive anterior abdominal wall scar tissue and attenuated fascia, removal of all staples, pain medication, incision/drainage of seroma with repeat multilayer closure of the abdominal wound, fibrinous debris scooped out, and drainage catheter removed.
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Event Description
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According to the reporter, the patient underwent an elective reversal of colostomy.It was reported that during the vent the gia stapler did not fire all of its staples.The two remaining ends of the patient¿s colon were re-anastomosed using an eea stapler.After the event, the patient experienced focal surface erosion/ulceration, gastroesophageal reflux disease, neck pain, granulation tissue changes, inflammation, fluid collection in abdomen/pelvis abscess, nodularity noted throughout the omentum and mesentery, enterococcus faecalis, moderate gnr, distention of splenic capsule, lymphoid hyperplasia, swollen lymph nodes, , hemaglobin, generalized weakness in upper and lower extremities, stocking like numbness in both hands, changes in balance and coordination of lower extremities, fecal diversion, open wound, ventral hernia with partial protrusion of non-obstructed segment of colon, seroma, staphylococcus aureus, small air bubbles in abdomen, hematoma, infection, induration, diverticulosis, atelectasis, hypoxemia, mucus plugs, mucus mucopurulent, sepsis, anastomotic leak, septic shock with peritonitis, dehiscence of sigmoid anastomosis with fecal peritonitis, feculent green fluid encountered in pelvis/ subdiaphragmatic areas/gutter, acute postprocedural respiratory failure, acute/subacute hepatic failure without coma, metabolic encephalopathy, complications of digestive system, acute kidney failure, disorder of phosphorus met abolism, pain, adhesions, tachycardia, wound dehiscence, copious serosanguinous drainage, wound drainage, necrotic adipose tissue, pale, clammy, hypertensive, hypothermic, purulent drainage with strong odor, necrotic tissue, small bowel beaten up, bleeding from surgical site, abdominal pain, pulling sensation, tender bulge in midline of abdomen, fibrotic scar tissue, attenuated fascia, distention, fibrinous debris, abdominal discomfort, orange thin liquid leaking from abdomen, chills, lack of energy, abdominal nausea and constipation.Patient treatments included hospitalization, icu in stable but critical condtion, neo-synephrine for pressor support, mechanically ventilated/intubated, bronchoscopy, antibiotics, peritoneal washout, oversew distal rectosigmoid, mobilization of splenic flexure, proximal end sigmoid colostomy, skin loosely approximated to allow drainage, dobhoff in place for tube feedings, neo-synephrine discontinued, placement of pigtail drainage catheter, fluid aspirated, iv fluid resuscitation, central line and arterial line placements, foley catheter, sedation, pain management, physical therapy, serial ct scans, daily labs, wound care, tube feedings, advancement of diet, open colostomy reversal, abdominal wall reconstruction with primary repair of ventral hernias, diverting loop ileostomy, placement of temporary ureteral stents, took portion of the proximal rectum including the prior staple line, ileum severely retracted, stoma bridged using a piece of red rubber catheter, jp drain placement, wound care, occupational therapy, recreational therapy, open abdominal incision/drainage, debridement of anterior necrotic fat, wet-to-dry dressings, wound vac placement, debridement of necrotic tissue, wound care with medi-honey and aquacel, reduction of parastomal hernia, ileostomy takedown surgery, ileostomy closure, adhesiolysis, retracted fascia, small bowel resection, staples and scab removed in medical doctor office, repair of ventral incisional and stomal hernias via primary re-approximation of fascia followed by onlay mesh, excision of extensive anterior abdominal wall scar tissue and attenuated fascia, removal of all staples, pain medication, wound debridement, incision/drainage of seroma with repeat multilayer closure of the abdominal wound, fibrinous debris scooped out, and drainage catheter removed.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional info received: b7, g1, g2, g3, g6, h2 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, the patient underwent an elective reversal of colostomy.It was reported that during the vent the gia stapler did not fire all of its staples.The two remaining ends of the patient¿s colon were re-anastomosed using an eea stapler.After the event, the patient experienced focal surface erosion/ulceration, gastroesophageal reflux disease, neck pain, granulation tissue changes, inflammation, fluid collection in abdomen/pelvis abscess, nodularity noted throughout the omentum and mesentery, enterococcus faecalis, moderate gnr, distention of splenic capsule, lymphoid hyperplasia, swollen lymph nodes, hemaglobin, generalized weakness in upper and lower extremities, stocking like numbness in both hands, changes in balance and coordination of lower extremities, fecal diversion, open wound, ventral hernia with partial protrusion of non-obstructed segment of colon, seroma, staphylococcus aureus, small air bubbles in abdomen, hematoma, infection, induration, diverticulosis, atelectasis, hypoxemia, mucus plugs, mucus mucopurulent, sepsis, anastomotic leak, septic shock with peritonitis, dehiscence of sigmoid anastomosis with fecal peritonitis, feculent green fluid encountered in pelvis/subdiaphragmatic areas/gutter, acute postprocedural respiratory failure, acute/subacute hepatic failure without coma, metabolic encephalopathy, complications of digestive system, acute kidney failure, disorder of phosphorus metabolism, pain, adhesions, tachycardia, wound dehiscence, copious serosanguinous drainage, wound drainage, chronic wound, necrotic adipose tissue, pale, clammy, hypertensive, hypothermic, purulent drainage with strong odor, necrotic tissue, small bowel beaten up, bleeding from surgical site, abdominal pain, pulling sensation, tender bulge in midline of abdomen, fibrotic scar tissue, multiple scars, attenuated fascia, distention, fibrinous debris, abdominal discomfort, orange thin liquid leaking from abdomen, chills, lack of energy, abdominal nausea and constipation.Patient treatments included hospitalization, icu in stable but critical condition, neo-synephrine for pressor support, mechanically ventilated/intubated, bronchoscopy, antibiotics, peritoneal washout, oversew distal rectosi gmoid, mobilization of splenic flexure, proximal end sigmoid colostomy, skin loosely approximated to allow drainage, dobhoff in place for tube feedings, neo-synephrine discontinued, placement of pigtail drainage catheter, fluid aspirated, iv fluid resuscitation, central line and arterial line placements, foley catheter, sedation, pain management, physical therapy, serial ct scans, daily labs, wound care, tube feedings, advancement of diet, open colostomy reversal, abdominal wall reconstruction with primary repair of ventral hernias, diverting loop ileostomy, placement of temporary ureteral stents, took portion of the proximal rectum including the prior staple line, ileum severely retracted, stoma bridged using a piece of red rubber catheter, jp drain placement, wound care, occupational therapy, recreational therapy, open abdominal incision/drainage, debridement of anterior necrotic fat, wet-to-dry dressings, wound vac placement, debridement of necrotic tissue, wound care with medi-honey and aquacel, reduction of parastomal hernia, ileostomy takedown surgery, ileostomy closure, adhesiolysis, retracted fascia, small bowel resection, staples and scab removed in medical doctor office, repair of ventral incisional and stomal hernias via primary re-approximation of fascia followed by onlay mesh, excision of extensive anterior abdominal wall scar tissue and attenuated fascia, removal of all staples, pain medication, wound debridement, incision/drainage of seroma with repeat multilayer closure of the abdominal wound, fibrinous debris scooped out, and drainage catheter removed.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional info: b5, b6, b7 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, the patient underwent an elective reversal of colostomy.It was reported that during the vent the gia stapler did not fire all of its staples.The two remaining ends of the patient¿s colon were re-anastomosed using an eea stapler.After the event, the patient experienced focal surface erosion/ulceration, gastroesophageal reflux disease, neck pain, granulation tissue changes, inflammation, fluid collection in abdomen/pelvis abscess, nodularity noted throughout the omentum and mesentery, enterococcus faecalis, moderate gnr, distention of splenic capsule, lymphoid hyperplasia, swollen lymph nodes, hemaglobin, generalized weakness in upper and lower extremities, stocking like numbness in both hands, changes in balance and coordination of lower extremities, fecal diversion, open wound, ventral hernia with partial protrusion of non-obstructed segment of colon, seroma, staphylococcus aureus, small air bubbles in abdomen, hematoma, infection, induration, diverticulosis, atelectasis, hypoxemia, mucus plugs, mucus mucopurulent, sepsis, anastomotic leak, septic shock with peritonitis, dehiscence of sigmoid anastomosis with fecal peritonitis, feculent green fluid encountered in pelvis/subdiaphragmatic areas/gutter, acute postprocedural respiratory failure, acute/subacute hepatic failure without coma, metabolic encephalopathy, complications of digestive system, acute kidney failure, disorder of phosphorus metab olism, pain, adhesions, tachycardia, wound dehiscence, copious serosanguinous drainage, wound drainage, chronic wound, necrotic adipose tissue, pale, clammy, hypertensive, hypothermic, purulent drainage with strong odor, necrotic tissue, small bowel beaten up, ble eding from surgical site, abdominal pain, pulling sensation, tender bulge in midline of abdomen, fibrotic scar tissue, multiple scars, attenuated fascia, distention, fibrinous debris, abdominal discomfort, orange thin liquid leaking from abdomen, chills, lack of e nergy, dehiscence due to heavy lifting, abdominal nausea and constipation.Patient treatments included hospitalization, icu in stable but critical condition, neo-synephrine for pressor support, mechanically ventilated/intubated, bronchoscopy, antibiotics, peritoneal washout, oversew distal rectosigmoid, mobilization of splenic flexure, proximal end sigmoid colostomy, skin loosely approximated to allow drainage, dobhoff in place for tube feedings, neo-synephrine discontinued, placement of pigtail drainage catheter, fluid aspirated, iv fluid resuscitation, central line and arterial line placements, foley catheter, sedation, pain management, physical therapy, serial ct scans, daily labs, wound care, tube feedings, advancement of diet, open colostomy reversal, abdominal wall reconstruction with primary repair of ventral hernias, diverting loop ileostomy, placement of temporary ureteral stents, took portion of the proximal rectum including the prior staple line, ileum severely retracted, stoma bridged using a piece of red rubber catheter, jp drain placement, wound care, occupational therapy, recreational therapy, open abdominal incision/drainage, debridement of anterior necrotic fat, wet-to-dry dressings, wound vac placement, debridement of necrotic tissue, wound care with medi-honey and aquacel, reduction of parastomal hernia, ileostomy takedown surgery, ileostomy closure, adhesiolysis, retracted fascia, small bowel resection, staples and scab removed in medical doctor office, repair of ventral incisional and stomal hernias via primary re-approximation of fascia followed by onlay mesh, excision of extensive anterior abdominal wall scar tissue and attenuated fascia, removal of all staples, pain medication, wound debridement, incision/drainage of seroma with repeat multilayer closure of the abdominal wound, fibrinous debris scooped out, removal of stitches, wound packed with gauze, augmentin prescribed, and drainage catheter removed.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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