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Model Number TECT1510AR |
Device Problems
Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Erosion (1750); Pain (1994); Therapeutic Effects, Unexpected (2099); Hernia (2240); Discomfort (2330); Injury (2348); No Code Available (3191); Unspecified Tissue Injury (4559)
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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 therapeutic treatment of a hernia.It was reported that after a procedure where this device was implanted, the patient experienced recurrence, chronic groin pain and mesh revision.After treatment, the patient experienced revision surgery.
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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 therapeutic treatment of a right inguinal hernia.It was reported that after preperitoneal implant, the patient experienced recurrence, mesh erosion, and chronic groin pain/pain.Post-operative patient treatment included revision surgery, right groin exploration, mesh removal, and additional implant for right inguinal hernia.
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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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Manufacturer Narrative
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This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 right inguinal hernia.It was reported that after preperitoneal implant, the patient experienced recurrence and chronic groin pain.After treatment, the patient experienced revision surgery, mesh removal, right groin exploration, mesh removal and additional implant for right inguinal hernia.
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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 right inguinal hernia.It was reported that after a procedure where this device was implanted, the patient experienced recurrence and chronic groin pain.After treatment, the patient experienced revision surgery, mesh removal, right groin exploration and additional implant for right inguinal hernia.
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Manufacturer Narrative
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This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.If information is provided in the future, a supplemental report will be issued.
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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 right inguinal hernia.It was reported that after preperitoneal implant, the patient experienced pain, digestive problems, discomfort in abdomen when lifting or walking, difficulty lifting anything over head, scrotum pain, soreness in lower abdomen, recurrence, mesh erosion, and chronic groin pain.Post-operative patient treatment included partial mesh removal, nerve block around ilioinguinal nerve, revisionsurgery, right groin exploration, mesh removal, and additional implant for right inguinal hernia.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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