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Model Number PCO2015X |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Fistula (1862); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Scarring (2061); Seroma (2069); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Post Operative Wound Infection (2446); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559); 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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Medtronic complaint report: (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 resulting an unspecified adverse outcome.Product was used for therapeutic treatment.Preoperative and postoperative diagnosis was chronic panniculitis and ventral hernia.The procedure performed was panniculectomy, intra-abdominal lysis of adhesions and ventral hernia repair with mesh, debridement along with adhesiolysis and former mesh was removed.(b)(6) 2014 - the patient underwent a revision for repair of recurrent hernia, debridement of wound including skin, subcutaneous tissue, and muscle, lysis of intraabdominal adhesions and placement of wound vac of 150 sq.Cm.Of wound.The pre-op diagnosis was open wound of abdomen, complex and post-op diagnosis was open wound of abdomen, complex, with infected hernia mesh.The patient experienced pain, adhesions, infection, non-healing wound, abscess, and scarring.
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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 a ventral hernia with chronic panniculitis.It was reported that after implant, the patient experienced pain, adhesions, infection, mrsa positive, non-healing wound with drainage, abscess, recurrence, fibroadipose tissue, inflammation, foreign body giant cell reaction, and scarring.Post-operative patient treatment included revision surgery, debridement of wound of all devitalized tissue including skin and muscle, lysis of adhesions, mesh removal, wound vac placement, and resection of skin and tissue.
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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 with chronic panniculitis.It was reported that after implant, the patient experienced pain, adhesions, infection, (b)(6), non-healing wound with drainage, abscess, scarring,.Post-operative patient treatment included revision surgery, debridement of wound of all devitalized tissue including skin and muscle, lysis of adhesions, mesh removal, wound vac placement, and resection of skin and tissue.
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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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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.Patient code: c64343 (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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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 with chronic panniculitis.It was reported that after implant, the patient experienced pain, adhesions, infection, mrsa positive, non-healing wound with drainage, abscess and scarring.Post-operative patient treatment included revision surgery, debridement of wound of all devitalized tissue including skin and muscle, lysis of adhesions, mesh removal, wound vac placement, and resection of skin and tissue.
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Search Alerts/Recalls
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