Model Number PCO9X |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Pain (1994); Tissue Damage (2104); Hernia (2240); Injury (2348); Abdominal Distention (2601); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent a laparoscopic incisional hernia repair and core liver biopsy.The preoperative and postoperative diagnosis was incisional hernia.The patient underwent a surgical revision approximately 2 months post op.In that revision the surgeon nicked the intestines.The patient experienced pain, abdominal distention and bowel resection.
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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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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 incisional hernia.It was reported that after implant, the patient experienced recurrence, adhesions, migration, pain, and abdominal distention.Post- operative treatment included hernia repair, lysis of adhesion, and small bowel resection.
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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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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 incisional hernia.It was reported that after implant, the patient experienced recurrence, adhesions, migration, abdominal pain, and abdominal distention.Post- operative treatment included hernia repair, lysis of adhesion, and small bowel resection.
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Search Alerts/Recalls
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