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Model Number P151020 |
Device Problems
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); Calcium Deposits/Calcification (1758); Cellulitis (1768); Emotional Changes (1831); Fistula (1862); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Seroma (2069); Discomfort (2330); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); Fibrosis (3167); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant product: pco20 parietex comp 3d py 20 cir nothr, (lot # pje00574).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 implant, the patient experienced pain and infection.Post-operative patient treatment included revision surgery and wound vac.
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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 ventral hernia.It was reported that after the implant, the patient experienced pain, mental pain, suffering, disability, impairment, loss of enjoyment of life, loss of care/comfort/consortium, chronic inflammation, bowel necrosis, fistula, extensive bowel adhesions, bowel erosion, open wound, abdominal pain, enterotomy, defective parietex mesh, failure of parietex mesh, bowel deserosalization, and infection.Post-operative patient treatment included revision surgery, bowel resection, invasive surgery, surgery to remove and/or excise all or part of the defective parietex mesh, and wound vac.Information received indicates the patient is deceased.No information was provided regarding the circumstances of expiration or any association with the devices.
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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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Manufacturer Narrative
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Correction: b2, b5, h1 further review found no received information indicates the patient expiration could be associated with the device.This event has been reassessed to be reportable as a serious injury.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.
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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 ventral hernia.It was reported that after the implant, the patient experienced pain, mental pain, suffering, disability, impairment, loss of enjoyment of life, loss of care/comfort/consortium, chronic inflammation, bowel necrosis, fistula, extensive bowel adhesions, bowel erosion, open wound, abdominal pain, enterotomy, defective parietex mesh, failure of parietex mesh, bowel deserosalization, and infection.Post-operative patient treatment included revision surgery, bowel resection, invasive surgery, surgery to remove and/or excise all or part of the defective parietex mesh, and wound vac.
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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 ventral hernia.It was reported that after the implant, the patient experienced pain, mental pain, suffering, disability, impairment, loss of enjoyment of life, chronic inflammation, fistula, extensive bowel adhesions, bowel erosion, open wound, abdominal pain, enterotomy, bowel deserosalization, infection, fluid collection, anasarca, induration, fibrous tissue with focal necrosis and calcification, seroma, fibroadipose tissue, suture granuloma, cellulitis, abscess, drainage, swelling, scar tissue, abdominal wound.Post-operative patient treatment included revision surgery, bowel resection, invasive surgery, wound vac, ct scan, ultrasound guided needle abscess/fluid collection drainage, multiple aspirations of abdominal wall, multiple hospitalizations, debridement of right abdominal wall/washout with packing, excision of seroma cavity, exploratory laparotomy, mesh closed with suture, incision and drainage of abdominal wound.
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Manufacturer Narrative
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H6 (patient codes, ime e2402: anasarca, induration, fibroadipose tissue).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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