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Model Number TEM1515G |
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); Calcium Deposits/Calcification (1758); Foreign Body Reaction (1868); Granuloma (1876); Muscle Weakness (1967); Necrosis (1971); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Foreign Body In Patient (2687); Fibrosis (3167); No Code Available (3191); Neuralgia (4413); Nodule (4551); Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 a hernia.It was reported that after the implant, the patient experienced mesh had rolled slightly and was impinging on nerves, meshoma, pain, recurrence and neuroma.Post-operative patient treatment included revision surgery.
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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 hernia.It was reported that after the onlay implant, the patient experienced mesh had rolled slightly and was impinging on nerves, meshoma, pain, recurrence, fibroconnective soft tissue, degenerative changes, necrosis, meshoma, fibrous tissue, dystrophic calcifications, histiocytic, foreign body giant cell response, palpable nodule, and neuroma/neuralgia.Post-operative patient treatment included revision surgery, surgical procedure involving peritoneum, removal of mesh and debridement, neurectomy, excision of left inguinal nerves, hernia closed with sutures, and excision of soft tissue.
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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 hernia.It was reported that after the onlay implant, the patient experienced mesh had rolled slightly and was impinging on nerves, pain, recurrence, fibroconnective soft tissue, degenerative changes, necrosis, meshoma, fibrous tissue, dystrophic calcifications, histiocytic, foreign body giant cell response, palpable nodule, neuroma/neuralgia, adhesions, abdominal pain, foreign body material, scar tissue, granuloma, diastasis, and nerve damage.Post-operative patient treatment included revision surgery, surgical procedure involving peritoneum, removal of mesh/sutures, debridement, neurectomy, excision of left inguinal nerves, hernia closed with sutures, excision of soft tissue, hernia repair with new mesh, lysis of adhesions, diagnostic laparoscopy, biopsy of foreign material, excision of foreign body abdominal wall, removal of granuloma, and meshoma removed.
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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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