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Model Number PCO1510X |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)
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Patient Problems
Wound Dehiscence (1154); Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Ischemia (1942); Necrosis (1971); Internal Organ Perforation (1987); Hernia (2240); Impaired Healing (2378); Obstruction/Occlusion (2422); Fibrosis (3167); Unspecified Tissue Injury (4559)
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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 a laparoscopic therapeutic treatment of a ventral hernia.It was reported that after the implant, the patient experienced prior mesh ripped on one side, small bowel incarcerated which cut off blood supply and necrotic, bowel obstruction, hernia recurrence, small bowel perforation, wound dehiscence, enterotomy in small bowel and stool all over abdominal cavity, mesh migration, infection, open wound, and adhesions.Post-operative patient treatment included explant of prior mesh, resection of small bowel, hernia repair with sutures, debridement of fascial tissue, lysis of adhesions, wound vac, 6 open abdominal washouts, open abdominal wall closure with mesh, and revision surgery.
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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 a laparoscopic therapeutic treatment of a ventral hernia.It was reported that after the implant, the patient experienced prior mesh ripped on one side, small bowel incarcerated which cut off blood supply, necrotic, bowel obstruction, hernia recurrence, small bowel perforation, wound dehiscence, enterotomy in small bowel and stool all over abdominal cavity, mesh migration, infection, open wound, fibrinous tissue, serosal tears, abdominal pain, and adhesions.Post-operative patient treatment included explant of prior mesh, resection of small bowel, hernia repair with sutures, debridement of fascial tissue, lysis of adhesions, wound vac, 6 open abdominal washouts, readmitted to hospital with 6 surgeries done, diagnostic laparoscopy, separation of components, open abdominal wall closure with mesh, and revision surgery.
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Search Alerts/Recalls
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