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Model Number PCO9X |
Device Problems
Material Erosion (1214); Migration or Expulsion of Device (1395); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Cyst(s) (1800); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Discharge (2225); Hernia (2240); Ulcer (2274); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Blood Loss (2597); Weight Changes (2607); Bowel Perforation (2668); Fibrosis (3167); No Code Available (3191); Sexual Dysfunction (4510); Cramp(s) /Muscle Spasm(s) (4521); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Medtronic complaint report: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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The patient's attorney alleged a deficiency against the device resulting an unspecified adverse outcome.Product was used for therapeutic treatment.Preoperative and postoperative diagnosis was ventral incisional hernia.The procedure performed was laparoscopic lysis of adhesions and ventral hernia repair.On (b)(6) 2017 -the patient underwent an panoramic hysteroscopy, endometrial curettage, fluoroscopy with placement of bilateral ureteral stents and removal at the end of the surgery, laparoscopy with extensive enterolysis, and extension of umbilical incision for mini laparotomy for enterolysis as well.The pre-op diagnosis was bilateral hydrosalpinx, suspected ovarian cyst, abnormal excessive uterine bleeding, abnormal pap smear, deep pelvic dyspareunia, obesity, and history of ulcerative colitis and post-operative hydrosalpinx, abnormal uterine bleeding, deep pelvic dyspareunia, obesity, history of ulcerative colitis, displaced intrabdominal mass with severe bowel adhesive disease with loop and bend formation, and frozen pelvis.On (b)(6) 2017 - the patient underwent a procedure for da vinci robotic assisted extensive lysis of adhesions enterolysis bilateral uretero lysis, total laparoscopic hysterectomy, bilateral salpingo-oophorectomy and cystoscopy.Pre-op diagnosis was severe menometrorrhagia dysmenorrhea known pelvic adhesive disease and post-op diagnosis was severe menometrorrhagia, dysmenorrhea, known pelvic adhesive disease, with large abdominal wall hernia, severe abdominopelvic adhesive disease and bilateral retroperitoneal fibrosis.On (b)(6) 2017 the patient underwent a laparoscopic incisional hernia repair with mesh.(b)(6) 2017 - the patient underwent a procedure for second look exploratory laparotomy, abdominal washout, removal of mesh with primary repair of hernia, fascial closure and placement of wet-to-dry dressing.The pre-op diagnosis was open abdomen with feculent material and the post-op diagnosis was closed open abdomen with concern for small bowel leakage.The patient experienced "displaced mesh identified; small bowel densely adherent to the anterior abdominal wall at level of mesh; removal of mesh".
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Manufacturer Narrative
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This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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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The patient's attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced displaced mesh, mesh migration, pain, small bowel obstruction, infection, hernia recurrence, mesh erosion into viscera, intestinal perforation, abscess, adhesions, bilateral hydrosalpinx, suspected ovarian cyst, abnormal excessive uterine bleeding, deep pelvic dyspareunia, obesity, ulcerative colitis and post-operative hydrosalpinx, displaced intrabdominal mass with severe bowel adhesive disease with loop and bend formation, and frozen pelvis, menometrorrhagia, dysmenorrhea, bilateral retroperitoneal fibrosis, open abdomen with feculent material, small bowel densely adherent to the anterior abdominal wall at level of mesh, prerenal azotemia, ascites and severe inflammation of viscera.Post-operative patient treatment included panoramic hysteroscopy, endometrial curettage, fluoroscopy with placement of bilateral ureteral stents and removal at the end of the surgery, laparoscopy with extensive enterolysis, and extension of umbilical incision for mini laparotomy for enterolysis, extensive lysis of adhesions enterolysis bilateral ureterolysis, total laparoscopic hysterectomy, colectomy, bilateral salpingo-oophorectomy and cystoscopy, laparoscopic incisional hernia repair with mesh, second look exploratory laparotomy, abdominal washout, removal of mesh with primary repair of hernia, fascial closure and placement of wet-to-dry dressing, closed open abdomen, removal of mesh, small bowel resection, neg pressure wound vac, and guided abscess drainage.
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Manufacturer Narrative
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This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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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The patient's attorney alleged a deficiency against the device.Product was used for laparoscopic therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced displaced mesh, hernia recurrence, mesh erosion into viscera, intestinal perforation, abscess, adhesions, bilateral hydrosalpinx, suspected ovarian cyst, abnormal excessive uterine bleeding, deep pelvic dyspareunia, obesity, ulcerative colitis and post-operative hydrosalpinx, displaced intrabdominal mass with severe bowel adhesive disease with loop and bend formation, and frozen pelvis, menometrorrhagia, dysmenorrhea, bilateral retroperitoneal fibrosis, open abdomen with feculent material, small bowel densely adherent to the anterior abdominal wall at level of mesh, prerenal azotemia, ascites and severe inflammation of viscera.Post-operative patient treatment included panoramic hysteroscopy, endometrial curettage, fluoroscopy with placement of bilateral ureteral stents and removal at the end of the surgery, laparoscopy with extensive enterolysis, and extension of umbilical incision for mini laparotomy for enterolysis, extensive lysis of adhesions enterolysis bilateral ureterolysis, total laparoscopic hysterectomy, colectomy, bilateral salpingo-oophorectomy and cystoscopy, laparoscopic incisional hernia repair with mesh, second look exploratory laparotomy, abdominal washout, removal of mesh with primary repair of hernia, fascial closure and placement of wet-to-dry dressing, closed open abdomen, removal of mesh, mall bowel resection, neg pressure wound vac, and guided abscess drainage.
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Manufacturer Narrative
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This information was received as a part of an extensive mesh litigation submission to medtronic. the fda was notified of this large complaint receipt. due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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.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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The patient's attorney alleged a deficiency against the device.Product was used for laparoscopic therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced displaced mesh, recurrence, mesh erosion into viscera, intestinal perforation, abscess, large amount of feculent, fibrin and turbid fluid, adhesions, bilateral hydrosalpinx, suspected ovarian cyst, abnormal excessive uterine bleeding, deep pelvic dyspareunia, obesity, and history of ulcerative colitis and post-operative hydrosalpinx, displaced intrabdominal mass with severe bowel adhesive disease with loop and bend formation, and frozen pelvis, menometrorrhagia, dysmenorrhea, large abdominal wall hernia, bilateral retroperitoneal fibrosis, open abdomen with feculent material, small bowel densely adherent to the anterior abdominal wall at level of mesh.Post-operative patient treatment included panoramic hysteroscopy, endometrial curettage, fluoroscopy with placement of bilateral ureteral stents and removal at the end of the surgery, laparoscopy with extensive enterolysis, and extension of umbilical incision for mini laparotomy for enterolysis, extensive lysis of adhesions enterolysis bilateral ureterolysis, total laparoscopic hysterectomy, colectomy, bilateral salpingo-oophorectomy and cystoscopy, laparoscopic incisional hernia repair with mesh, second look exploratory laparotomy, abdominal washout, removal of mesh with primary repair of hernia, fascial closure and placement of wet-to-dry dressing, closed open abdomen, removal of mesh, mall bowel resection, neg pressure wound vac, and guided abscess drainage.
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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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The patient's attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced abdominal pain in both sides, abdominal cramping when bending over, displaced mesh, mesh migration, pain, small bowel obstruction, infection, hernia recurrence, mesh erosion into viscera, intestinal perforation, abscess, adhesions, bilateral hydrosalpinx, suspected ovarian cyst, abnormal excessive uterine bleeding, deep pelvic dyspareunia, obesity, ulcerative colitis and post-operative hydrosalpinx, displaced intrabdominal mass with severe bowel adhesive disease with loop and bend formation, and frozen pelvis, menometrorrhagia, dysmenorrhea, bilateral retroperitoneal fibrosis, open abdomen with feculent material, small bowel densely adherent to the anterior abdominal wall at level of mesh, prerenal azotemia, ascites and severe inflammation of viscera.Post-operative patient treatment included 14 day inpatient hospitalization, medication, small bowel resection, diagnostic laparoscopy, ct scan, da vinci robotic assisted extensive lysis of adhesions panoramic hysteroscopy, endometrial curettage, fluoroscopy with placement of bilateral ureteral stents and removal at the end of the surgery, laparoscopy with extensive enterolysis, and extension of umbilical incision for mini laparotomy for enterolysis, extensive lysis of adhesions enterolysis bilateral ureterolysis, total laparoscopic hysterectomy, colectomy, bilateral salpingo-oophorectomy and cystoscopy, laparoscopic incisional hernia repair with mesh, second look exploratory laparotomy, abdominal washout, removal of mesh with primary repair of hernia, fascial closure and placement of wet-to-dry dressing, closed open abdomen, removal of mesh, small bowel resection, neg pressure wound vac, and guided abscess drainage.
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Search Alerts/Recalls
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