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Model Number SYM12 |
Device Problems
Migration or Expulsion of Device (1395); Material Integrity Problem (2978); 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); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Hernia (2240); Unspecified Tissue Injury (4559)
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Event Type
Injury
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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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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 implant, the patient experienced product failure, mesh migration and contraction, adhesions to the omentum/bowel/other intraabdominal structures, hernia recurrence, scar tissue, chronic pain, inflammation, bowel necrosis, fistula, bowel adhesions, bowel deserosalization, bowel erosion, enterotomy, defective device, suffering, disability, impairment, and loss of enjoyment of life.Post-operative patient treatment included revision surgery, removal surgery, and bowel resection.
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Manufacturer Narrative
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Additional info: a1, a2, a3a, a5b, b5, b6, b7, d6a, d6b, d10, g1, <(>&<)> h6 (patient codes) 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 incisional hernia.It was reported that after implant, the patient experienced product failure, mesh migration and contraction, adhesions to the ome ntum/bowel/other intraabdominal structures, hernia recurrence, scar tissue, chronic pain, inflammation, bowel necrosis, fistula, bowel adhesions, bowel deserosalization, bowel erosion, enterotomy, defective device, suffering, disability, impairment, loss of enjoyment of life, <(>&<)> infected mesh.Post-operative patient treatment included revision surgery, removal surgery, bowel resection, ct scan, lysis of adhesions, <(>&<)> use of abdominal binder.
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Search Alerts/Recalls
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