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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The patient's attorney alleged a deficiency against the device.
Product was used for therapeutic treatment of a supraumbilical midline ventral hernia.
It was reported that after implant, the patient experienced recurrence, pain, dense adhesions, necrotic ileum and small bowel, open draining wound, perforated appendix, abdominal pain, and chronic mesenteric ischemia.
Post-operative patient treatment included revision surgeries, recurrence, repair of hernia with mesh, exploratory laparotomy, lysis of adhesions, resection of 35 cm of small bowel, placement of wound vac, primary anastomosis of the ileum, appendectomy, small bowel resection, enteroerostomy, abdominal closure, and wound vac.
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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 had revision surgery 3 years and 5 months post-surgery.
The patient experienced pain, hernia recurrence, revision surgeries, significant adhesions to bowels and open draining wound.
External contact and facility is not available because source document is not received.
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