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Model Number SYM1510 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Fistula (1862); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Vomiting (2144); Hernia (2240); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); No Code Available (3191); 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 a hernia.It was reported that after implant, the patient experienced mesh failure, obstruction, adhesions, abscess and infection.Post-operative patient treatment included revision/removal, adhesion removal and small bowel resection.
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Manufacturer Narrative
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Concomitant devices: securestrap (product id: strap25, lot number: lgk345); securestrap (product id: strap25, lot number: lck352).H6: patient codes-c64343 (fecalization of bowel content, mass).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.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 parastomal hernia.It was reported that after implant, the patient experienced mesh failure, obstruction, adhesions, abscess, enteritis, focalization of bowel content, fistula, tender mass, dehiscence, abdominal pain, nausea, vomiting, and infection.Post-operative patient treatment included revision surgery, removal of mesh, infected granulation tissue excised, hernia repair with new mesh, incision/drainage of abdominal wall abscess, lysis of adhesions, fluid aspirated from abscess, and small bowel resection.
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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 parastomal hernia.It was reported that after implant, the patient experienced mesh failure, obstruction, adhesions, abscess, enteritis, fecalization of bowel content, hernia, fistula, tender mass, dehiscence, abdominal pain, nausea, vomiting, and infection.Post-operative patient treatment included revision surgery, removal of mesh, infected granulation tissue excised, hernia repair with new mesh, incision/drainage of abdominal wall abscess, lysis of adhesions, fluid aspirated from abscess, and small bowel resection.
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Manufacturer Narrative
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Additional information: a4 (weight in lbs).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.
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Search Alerts/Recalls
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