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Model Number SYM12 |
Device Problems
Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Atrial Fibrillation (1729); Emotional Changes (1831); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Chills (2191); Dizziness (2194); Anxiety (2328); Distress (2329); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Constipation (3274); 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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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 umbilical hernia.It was reported that after implant, the patient experienced suffering, diminished quality of life, desmoplastic reaction of omentum and small bowel, bowel contracted, folded, and matted with small hairpin turns that caused obstruction, premature resorption of collagen coating, bowel problems, mental anguish, defective device, mesh failure, impairment, loss of enjoyment of life, pain, emotional distress, mental pain, adhesions, inflammation, infection, and disability.Post-operative patient treatment included revision surgery.
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Manufacturer Narrative
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(b)(4).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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Manufacturer Narrative
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Additional info: a1, a2 (date of birth), d4 (expiration date, lot#, udi#), h6 (patient code, imf code).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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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 umbilical hernia.It was reported that after implant, the patient experienced abdominal pain, suffering, diminished quality of life, desmoplastic reaction of omentum and small bowel, bowel contracted, folded, and matted with small hairpin turns that caused obstruction, premature resorption of collagen coating, bowel problems, mental anguish, defective device, mesh failure, impairment, loss of enjoyment of life, pain, emotional distress, mental pain, adhesions, inflammation, infection, and disability.Post-operative patient treatment included revision surgery, mesh revision, hospitalization for small bowel obstruction, exploratory laparotomy and lysis of adhesions.
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Manufacturer Narrative
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Additional info: h6 (patient codes, imf codes, ime e2402: "desmoplastic reaction, abnormal wbc, hematocrit, leukocytosis and glucose, gas collection").D10: securestrap absorbable fixation: product id: strap25, lot number: elm312.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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Event Description
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The patient's attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of an in coacervated umbilical hernia.It was reported that after implant, the patient experienced jejunal obstruction, platelike mesenteric scarring, distention of stomach, small bowel loop dilatation, fluid and gaseous distention, labs abnormal for wbc and glucose, constipation, nausea, chills, dizziness, serosal tears, fever, atrial fibrillation, anxiety, agitation, drainage at umbilicus, abdominal pain, suffering, diminished quality of life, desmoplastic reaction of omentum and small bowel, bowel contracted, folded, and matted with small hairpin turns that caused obstruction, premature resorption of collagen coating, bowel problems, mental anguish, defective device, mesh failure, impairment, loss of enjoyment of life, pain, emotional distress, mental pain, adhesions, inflammation, infection, and disability.Post-operative patient treatment included ct scan, x-ray, nasogastric tube decompression, iv fluids, iv pain medication, iv antiemetics, iv antibiotics, intubation, iv cardiac medications, revision surgery, mesh revision, hospitalization for small bowel obstruction, icu stay, exploratory laparotomy and lysis of adhesions.
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Search Alerts/Recalls
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