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Model Number SYM9 |
Device Problems
Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Bruise/Contusion (1754); Cellulitis (1768); Emotional Changes (1831); Fever (1858); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240); Discomfort (2330); Constipation (3274); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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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Concomitant medical products: product id: reltack3x10, reltack3x10, reliatack articulat reload a, lot number: n4m0869ux.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 abdominal pain, adhesions, and hernia recurrence.Post-operative patient treatment included additional surgery and hernia repair with mesh.
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Manufacturer Narrative
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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 ventral hernia.It was reported that after implant, the patient experienced abdominal pain, adhesions, hernia recurrence, pain, inflammation, mesh migration, mental pain, scarring, permanent impairment, loss of enjoyment of life and defective mesh.Post-operative patient treatment included additional surgery, mesh intervention surgery and hernia repair with mesh.
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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 a ventral incisional hernia.It was reported that after implant, the patient experienced abdominal pain, adhesions, hernia recurrence, pain, inflammation, mesh migration, mental pain, scarring, permanent impairment, loss of enjoyment of life, defective mesh, edema, cellulitis, constipation, tenderness, hard knot in umbilicus, nausea, defect in center of mesh, fever, extensive bruising to lower abdomen.Post-operative patient treatment included additional surgery, mesh intervention surgery, hernia repair with mesh, ct scan, hospitalization, pain medication, & enemas.
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Manufacturer Narrative
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Additional info: h6 (patient codes, device codes, ime e2402: knot).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: h6 (patient codes, ime e2402: "protrusion of umbilicus").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 laparoscopic therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced infection, bleeding, seroma, swelling, protrusion of umbilicus, abdominal pain, adhesions, hernia recurrence, pain, inflammation, mesh migration, mental pain, scarring, permanent i mpairment, loss of enjoyment of life, defective mesh, edema, cellulitis, constipation, tenderness, hard knot in umbilicus, nausea, defect in center of mesh, fever, extensive bruising to lower abdomen.Post-operative patient treatment included medication, pain management, additional surgery, mesh intervention surgery, hernia repair with mesh, ct scan, hospitalization, pain medication, & enemas.
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Search Alerts/Recalls
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