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Model Number SYM2520 |
Device Problems
Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Emotional Changes (1831); Fistula (1862); Hypoxia (1918); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Discomfort (2330); Low Oxygen Saturation (2477); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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 hernia.It was reported that after implant, the patient experienced mental pain, pain, injury, disability, impairment, loss of enjoyment of life, defective mesh.Post-operative patient treatment included medical treatment.
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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 incisional hernia.It was reported that after implant, the patient experienced mental pain, pain, injury, disability, impairment, loss of enjoyment of life, defective mesh, infection, adhesions, fistula, joint stiffness, & unable to lift over 5lbs.Post-operative patient treatment included medical treatment, exploratory laparotomy, hernia repair with mesh, bowel resection, possible ostomy, possible hernia repair, & medication.
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Manufacturer Narrative
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Additional info: a2, a3, a4, b5, b7, d4, g1, & 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 an incisional hernia.It was reported that after implant, the patient experienced mental pain, pain, injury, disability, impairment, loss of enjoyment of life, defective mesh, infection, adhesions, fistula, joint stiffness, discomfort, inflammation, scarring, and unable to lift over 5lbs.Post-operative patient treatment included medical treatment, exploratory laparotomy, hernia repair with mesh, bowel resection, possible ostomy, possible hernia repair, and medication.
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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 incisional hernia.It was reported that after implant, the patient experienced mental pain, pain, injury, disability, impairment, loss of enjoyment of life, defective mesh, infection, adhesions, fistula, joint stiffness, discomfort, inflammation, scarring, unable to lift over 5lbs, fistulization of small & large bowel, phlegmon, induration, murky fluid, & acute hypoxic event with oxygen saturation low.Post-operative patient treatment included medical treatment, exploratory laparotomy, hernia repair with mesh, bowel resection, possible ostomy, possible hernia repair, medication, antibiotics, incision & drainage of phlegmon, seromuscular tear repaired with suture, reduction of hernia, mesh removal, & oxygenation treatment.
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Manufacturer Narrative
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Additional info: h6 (patient codes, ime e2402: induration) 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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Search Alerts/Recalls
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