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Model Number SPM-35-W |
Device Problems
Degraded (1153); Material Deformation (2976); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Calcium Deposits/Calcification (1758); Emotional Changes (1831); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Hernia (2240); Anxiety (2328); Discomfort (2330); Depression (2361); Abdominal Distention (2601); Fluid Discharge (2686); 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 defective mesh, mental and physical pain, disability, impairment, loss of enjoyment of life, inflammation, bacterial infection, mesh degradation, mesh deformed, mesh not incorporated, chronic draining abscess, recurrence, mesh eventration, scar tissue, pain, calcified necrotic fat tissue, and adhesions.Post-operative patient treatment included revision surgery, removal of mesh, medication, hernia repair with mesh, and lysis of adhesions.
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Manufacturer Narrative
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Additional info: a4, b5, b7, d3 (mfr name, street, city, region, country code, postal code), h6 (patient codes).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 hernia.It was reported that after implant, the patient experienced depression, anxiety, digestive issues, bloating, soreness, defective mesh, mental and physical pain, disability, impairment, loss of enjoyment of life, inflammation, bacterial infection, mesh degradation, mesh deformed, mesh not incorporated, chronic draining abscess, recurrence, mesh eventration, scar tissue, pain, calcified necrotic fat tissue, and adhesions.Post-operative patient treatment included bowel resection, recurrent hernia repair, revision surgery, removal of mesh, medication, hernia repair with mesh, and lysis of adhesions.
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Search Alerts/Recalls
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