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Model Number PCO1510OSX |
Device Problems
Material Integrity Problem (2978); Mechanics Altered (2984); 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); Emotional Changes (1831); Fistula (1862); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Hernia (2240); Discomfort (2330); Deformity/ Disfigurement (2360); Obstruction/Occlusion (2422); Cancer (3262); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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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 incisional hernia.It was reported that after the implant, the patient experienced mental pain, pain/suffering, physical deformity, device defective, implant failure, mental anguish, scarring, disfigurement, mesh contraction, adhesion fistula, inflammation, foreign body response, scar tissue, organ perforation, recurrence, dyspareunia, blood loss, neuropathic, nerve damage, abdominal pain, infection, adhesions, enterocutaneous fistula, erosion of small bowel into underlay of mesh, abdominal wall abscess, umbilical discomfort and swelling.Post-operative patient treatment included exploratory laparotomy, lysis of adhesions, small bowel resection with primary anastomosis, mesh removal and sharp excision 20 cm of skin and subcutaneous tissue, attempt to repair organs, tissue, and nerve damage, enterocutaneous fistula takedown, use of pain control and other medications.
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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 incisional hernia.It was reported that after the implant, the patient experienced obstruction, recurrent cancer, mental pain, pain/suffering, physical deformity, device defective, implant failure, mental anguish, scarring, disfigurement, mesh contraction, adhesions, fistula, inflammation, foreign body response, scar tissue, organ perforation, recurrence, dyspareunia, blood loss, neuropathic, nerve damage, abdominal pain, infection, enterocutaneous fistula, erosion of small bowel into underlay of mesh, abdominal wall abscess, umbilical discomfort and swelling.Post-operative patient treatment included medication, exploratory laparotomy, lysis of adhesions, small bowel resection with primary anastomosis, mesh removal and sharp excision 20cm of skin and subcutaneous tissue, attempt to repair organs, tissue, and nerve damage, incision and drainage of complex abdominal wall abscess, removal of part of stomach, abdominal wall resection, enterocutaneous fistula takedown, use of pain control and other medications.
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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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Search Alerts/Recalls
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