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Model Number TEM1208GR |
Device Problems
Migration or Expulsion of Device (1395); Material Deformation (2976); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Emotional Changes (1831); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240); Distress (2329); Discomfort (2330); 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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(b)(4).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 inguinal hernia.It was reported that after the implant, the patient experienced mesh failure, spermatic cord involvement, strangulation of proximal cord structures, folded mesh, nerve damage, nerve entrapment, scarring, inflammation, foreign body reaction, neuropathic inguinodynia, pain, meshoma, adhesions, cord lipoma, attenuation, and recurrence.Post-operative patient treatment included revision surgery, hernia repair with new mesh, vascular control of the inferior epigastric takeoff off iliac vein, neurectomy of the right ilioinguinal nerve with proximal intramuscular reimplantation, neurectomy of the right iliohypogastric nerve with proximal intramuscular reimplantation, tissue closure of the floor of the inguinal canal, and removal of mesh.
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Manufacturer Narrative
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Additional info - b2, b5, e1, g1, h6 (patient, device, and health impact 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 inguinal hernia.It was reported that after the implant, the patient experienced emotional distress, discomfort, mental anguish, defective mesh, mental pain, disability, impairment, loss of enjoyment of life, mesh extruded from defect, disrupted mesh, bleeding, mesh failure, spermatic cord involvement, strangulation of proximal cord structures, folded mesh, nerve damage, nerve entrapment, scarring, inflammation, foreign body reaction, neuropathic inguinodynia, pain, meshoma, adhesions, cord lipoma, attenuation, and recurrence.Post-operative patient treatment included medications, nerve blocks, revision surgery, hernia repair with new mesh, vascular control of the inferior epigastric takeoff off iliac vein, neurectomy of the right ilioinguinal nerve with proximal intramuscular reimplantation, neurectomy of the right iliohypogastric nerve with proximal intramuscular reimplantation, tissue closure of the floor of the inguinal canal, and removal of 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.
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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 inguinal hernia.It was reported that after the implant, the patient experienced emotional distress, discomfort, mental anguish, defective mesh, mental pain, disability, impairment, loss of enjoyment of life, mesh extruded from defect, disrupted mesh, bleeding, mesh failure, spermatic cord involvement, strangulation of proximal cord structures, folded mesh, nerve damage, nerve entrapment, scarring, inflammation, foreign body reaction, neuropathic inguinodynia, pain, meshoma, adhesions, cord lipoma, attenuation, mesh migration, mesh shrink, scar tissue, and recurrence.Post-operative patient treatment included medications, nerve blocks, revision surgery, hernia repair with new mesh, vascular control of the inferior epigastric takeoff off iliac vein, neurectomy of the right ilioinguinal nerve with proximal intramuscular reimplantation, neurectomy of the right iliohypogastric nerve with proximal intramuscular reimplantation, tissue closure of the floor of the inguinal canal, and removal of mesh.Relevant tests/laboratory data: on (b)(6) 2019: pathology report from right inguinal mesh specimen showed chronic inflammation and foreign body giant cell reaction.
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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.
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Search Alerts/Recalls
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