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Model Number TECT1510AR |
Device Problems
Migration or Expulsion of Device (1395); Material Deformation (2976); Material Integrity Problem (2978); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Cyst(s) (1800); Emotional Changes (1831); Failure of Implant (1924); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Swelling (2091); Hernia (2240); Discomfort (2330); Injury (2348); Irritability (2421); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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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 laparoscopic therapeutic treatment of an inguinal hernia.It was reported that after the implant, the patient experienced swelling, right inguinal pain, recurrence, mesh entrapment neuropathy, adhesions, scar tissue, discomfort, mesh failure, mesh contraction, tenderness, inguinodynia, and mood changes/more irritable.Post-operative patient treatment included ilioinguinal/iliohypogastric nerve block and sacroiliac joint/lower lumbar trigger point injection.The injections failed to relieve the pain.
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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 inguinal hernia.It was reported that after the implant, the patient experienced swelling, right inguinal pain, recurrence, mesh entrapment neuropathy, adhesions, scar tissue, discomfort, mesh failure, mesh contraction, tenderness, inguinaldynia, pain, masses, nerve damage, cysts, and mood changes/more irritable.Post-operative patient treatment included ilioinguinal/iliohypogastric nerve block, revision surgeries, and sacroiliac joint/lower lumbar trigger point injection.The injections failed to relieve the pain.
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Manufacturer Narrative
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Additional information: b5, d8, e1 (facility name, street 1, city, region, postal code), g1, g3, h6 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 laparoscopic therapeutic treatment of an inguinal hernia.It was reported that after the implant, the patient experienced mesh migration, hemangioma, osteoarthritis, degenerative disc disease, irritability, swelling, right inguinal pain, recurrence, mesh entrapment neuropathy, adhesions, scar tissue, discomfort, mesh failure, mesh contraction, tenderness, inguinaldynia, pain, masses, nerve damage, cysts, and mood changes/more irritable.Post-operative patient treatment included ultrasound, mri, sonographic imaging, x-ray, ilioinguinal/iliohypogastric nerve block, revision surgeries, and sacroiliac joint/lower lumbar trigger point injection.It was noted that the injections failed to relieve the pain.
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Manufacturer Narrative
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Additional info: a4, b5, b7, h6 (patient codes, imf codes, device codes, ime e2402: "hemangioma, osteoarthritis, degenerative disc disease").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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Search Alerts/Recalls
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