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Model Number SYM9 |
Device Problems
Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Emotional Changes (1831); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240); Ascites (2596); Abdominal Distention (2601); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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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 ventral and umbilical hernia.It was reported that after implant, the patient experienced pain, recurrence, swelling, bulging, seroma, mesh failure, inflammation, infection, scarring, nerve damage, mental pain, disability, impairment, and loss of enjoyment of life.Post-operative patient treatment included revision and removal of mesh.
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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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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 ventral and umbilical hernia.It was reported that after implant, the patient experienced pain, recurrence, swelling, bulging, seroma, mesh failure, inflammation, infection, scarring, nerve damage, mental pain, disability, impairment, ascites, and loss of enjoyment of life.Post-operative patient treatment included removal of mesh, exploratory laparotomy, repair with new mesh.
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Search Alerts/Recalls
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