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Model Number PCO9X |
Device Problems
Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Dehydration (1807); Purulent Discharge (1812); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Renal Failure (2041); Sepsis (2067); Vomiting (2144); Hernia (2240); Impaired Healing (2378); Obstruction/Occlusion (2422); Fluid Discharge (2686); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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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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 therapeutic treatment of an incisional supr aumbilical ventral hernia.It was reported that after the underlay implant, the patient experienced infected mesh, wadded up mesh, adhesions, abdominal wall drainage, chronic wound, draining sinus tract, small bowel obstruction, edematous, inflammation, loss of domain, mass, purulent drainage, stitch granuloma, wound dehiscence, massive wound, fat necrosis, abscess, redness, serous leakage, vomiting, severely dehydrated, and recurrence.Post-operative patient treatment included revision surgery, removal of mesh, lysis of adhesions, open cholecystectomy, hernia repair with new mesh, small bowel resection, medication, daily wound dressing changes, bilateral subcutaneous skin flap creation, primary fascial closure, admission to hospital, suture material removed, excisional biopsy of omental mass, bilateral myofascial rectus abdominis advancement flaps, some purulent drainage/likely stitch granuloma were excised, and abdominal wall reconstruction.
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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 therapeutic treatment of an incisional supr aumbilical ventral hernia.It was reported that after the underlay implant, the patient experienced infected mesh, wadded up mesh, adhesions, abdominal wall drainage, chronic wound, draining sinus tract, small bowel obstruction, edematous, inflammation, loss of domain, mass, purulent drainage, stitch granuloma, wound dehiscence, massive wound, fat necrosis, abscess, redness, serous leakage, vomiting, severely dehydrated, and recurrence.Post-operative patient treatment included revision surgery, removal of mesh, lysis of adhesions, hernia repair with new mesh, small bowel resection, medication, daily wound dressing changes, bilateral subcutaneous skin flap creation, primary fascial closure, admission to hospital, suture material removed, excisional biopsy of omental mass, bilateral myofascial rectus abdominis advancement flaps, some purulent drainage/likely stitch granuloma were excised, excision of wound of abdomen, intermediate closure of abdominal incision, and abdominal wall reconstruction.
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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 information: b5, g3, h6 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 therapeutic treatment of an incisional supr aumbilical ventral hernia.It was reported that after the underlay implant, the patient experienced infected mesh, wadded up mesh, adhesions, abdominal wall drainage, chronic wound, draining sinus tract, small bowel obstruction, edematous, inflammation, loss of domain, mass, purulent drainage, stitch granuloma, wound dehiscence, massive wound, fat necrosis, abscess, redness, serous leakage, vomiting, severely dehydrated, pain, and recurrence.Post-operative patient treatment included revision surgery, removal of mesh, lysis of adhesions, hernia repair with new mesh, small bowel resection, medication, daily wound dressing changes, bilateral subcutaneous skin flap creation, primary fascial closure, admission to hospital, suture material removed, excisional biopsy of omental mass, bilateral myofascial rectus abdominis advancement flaps, some purulent drainage/likely stitch granuloma were excised, excision of wound of abdomen, intermediate closure of abdominal incision, and abdominal wall reconstruction.
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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 therapeutic treatment of an incisional supr aumbilical ventral hernia.It was reported that after the underlay implant, the patient experienced sepsis, acute renal failure, failed mesh, infected mesh, wadded up mesh, adhesions, abdominal wall drainage, chronic wound, draining sinus tract, small bowel obstruction, edematous, inflammation, loss of domain, mass, purulent drainage, stitch granuloma, wound dehiscence, massive wound, fat necrosis, abscess, redness, serous leakage, vomiting, severely dehydrated, pain, and recurrence.Post-operative patient treatment included jp drain, skin excision, ct scan, blake drains, icu admittance, revision surgery, removal of mesh, lysis of adhesions, hernia repair with new mesh, small bowel resection, medication, daily wound dressing changes, bilateral subcutaneous skin flap creation, primary fascial closure, admission to hospital, suture material removed, excisional biopsy of omental mass, bilateral myofascial rectus abdominis advancement flaps, some purulent drainage/likely stitch granuloma were excised, excision of wound of abdomen, intermediate closure of abdominal incision, and abdominal wall reconstruction.
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Search Alerts/Recalls
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