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Model Number SYM1510 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Hernia (2240); Discomfort (2330); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: tem1509g parietex progrip tem/pla 15x9cm (lot# ssa1659x).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 abdominal hernia.It was reported that after implant, the patient experienced recurrence, chronic pain, and discomfort.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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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 abdominal hernia.It was reported that after implant, the patient experienced recurrence, chronic pain, infection, inflammation, adhesions, obstruction, abdominal and pelvic sensitivity, and discomfort.Post-operative patient treatment included medication.
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Search Alerts/Recalls
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