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Model Number SYM12 |
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
Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Fistula (1862); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Hernia (2240); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559)
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Event Type
Injury
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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 failure of mesh, recurrence, pain, chronic inflammation, bowel necrosis, fistula, extensive bowel adhesion, bowel deserosalization, bowel erosion, enterotomy, defective mesh, mental pain, disability, impairment, loss of enjoyment of life, and adhesions.Post-operative patient treatment included revision surgery, bowel resection, and removal surgery.
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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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Manufacturer Narrative
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Additional info: a2 (date of birth), a3a, a4, b5, b7, d6b, h6 (patient codes, imf code).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 a hernia.It was reported that after the implant, the patient experienced scarring, muscle spasms, failure of mesh, recurrence, pain, chronic inflammation, bowel necrosis, fistula, extensive bowel adhesions, bowel deserosalization, bowel erosion, enterotomy, defective mesh, mental pain, disability, impairment, loss of enjoyment of life, and adhesions.Post-operative patient treatment included revision surgery,bowel resection, removal surgery, lysis of adhesions and hernia repair with new meshes.
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Search Alerts/Recalls
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