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Model Number TECR1510 |
Device Problems
Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Adhesion(s) (1695); Edema (1820); Fistula (1862); Granuloma (1876); Inflammation (1932); Muscle Weakness (1967); Neovascularization (1978); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Rash (2033); Scar Tissue (2060); Scarring (2061); Seroma (2069); Urinary Retention (2119); Hernia (2240); Discomfort (2330); Injury (2348); Numbness (2415); Fungal Infection (2419); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical product: endotak.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 laparoscopic treatment of bilateral inguinal hernias.It was reported that after implant, the patient experienced dense adhesions, scarring, neuropathy, recurrence, and disengagement of left groin mesh from host tissues.Post-operative patient treatment included revision surgery.The device had been used with endotak.
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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 laparoscopic treatment of bilateral inguinal hernias.It was reported that after implant, the patient experienced dense adhesions, scarring, neuropathy, recurrence, disengagement of left groin mesh from host tissues, nerve damage, scarification of the tissues, shrinkage of mesh, blood supply exceptionally diminished to left testicle and spermatic cord, granulomas, edematous, lack of incorporation, tenderness, pain, neovascularization, and spermatic cord displaced.Post-operative patient treatment included revision surgery, mesh removal, doppler confirmation of the blood supply of the left testicle and spermatic cord, right/left genitofemoral neurectomy/neuroplasty, right/left ilioinguinal neurectomy/neuroplasty, right iliohypogastric neurectomy/neuroplasty, removal of mesh granulomas with multiple foreign bodies, removal of suture, and hernia repair with new 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 therapeutic laparoscopic treatment of bilateral inguinal hernias.It was reported that after implant, the patient experienced inflammation, fistula, seroma, rashes, fungal and yeast infections, loss of sensation, urinary bladder distention, physical instability and weakness of lower abdomen and groin, dense adhesions, scarring, neuropathy, recurrence, disengagement of left groin mesh from host tissues, nerve damage, scarification of the tissues, shrinkage of mesh, blood supply exceptionally diminished to left testicle and spermatic cord, granulomas, edematous, lack of incorporation, tenderness, pain, neovascularization, and spermatic cord displaced.Post-operative patient treatment included medication, open exploration of left groin, revision surgery, mesh removal, doppler confirmation of the blood supply of the left testicle and spermatic cord, right/left genitofemoral neurectomy/neuroplasty, right/left ilioinguinal neurectomy/neuroplasty, right iliohypogastric neurectomy/neuroplasty, removal of mesh granulomas with multiple foreign bodies, removal of suture, and hernia repair with new meshes.Concomitant device: unknown endotak.
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Manufacturer Narrative
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Additional info: a4, b5, b7, d8, e1 (facility name, street, city, region, postal code), h6 (patient codes, imf 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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Search Alerts/Recalls
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