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Model Number P151520 |
Device Problems
Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Laceration(s) (1946); Internal Organ Perforation (1987); Perforation (2001); Discharge (2225); Hernia (2240); Peritonitis (2252); Injury (2348); Ascites (2596); Blood Loss (2597); Fluid Discharge (2686); 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 laparoscopic therapeutic treatment of a recurrent ventral hernia.It was reported that after implant, the patient experienced recurrence, extensive adhesions, serosal tears, abscess in left lateral abdominal area, leakage, and bleeding.Post-operative patient treatment included recurrent incisional hernia repair with new bard mesh, omentum and small bowel attached to the inferior aspect of the mesh were dissected, all segment of composite mesh extended to below the umbilicus at the midline was excised, placement of bard mesh, bowel was teased off of the mesh and the abdominal wall, repair of serosal tears, removal of previous mesh, placement of new covidien permacol mesh, drainage of intrabdominal abscess as well as three areas of small bowel required resection: part that had leaked, torn during lysis of adhesions, and was devascularized from tearing and having bleeding.
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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.Additional information: pma/510k.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 a recurrent ventral hernia.It was reported that after implant, the patient experienced recurrence, extensive adhesions, serosal tears, abscess in left lateral abdominal area, leakage, bleeding, and a perforation from a surgical complication.Post-operative patient treatment included recurrent incisional hernia repair with new bard mesh, omentum and small bowel attached to the inferior aspect of the mesh were dissected, all segment of composite mesh extended to below the umbilicus at the midline was excised, placement of bard mesh, bowel was teased off of the mesh and the abdominal wall, repair of serosal tears, removal of previous mesh, placement of new covidien permacol mesh, drainage of intrabdominal abscess as well as three areas of small bowel required resection: part that had leaked, torn during lysis of adhesions, and was devascularized from tearing and having bleeding.
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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.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 a recurrent ventral hernia.It was reported that after implant, the patient experienced recurrence, extensive adhesions, serosal tears, abscess in left lateral abdominal area, leakage, bleeding, infection, and peritonitis, and a perforation from a surgical complication.Post-operative patient treatment included recurrent incisional hernia repair with new bard mesh, omentum and small bowel attached to the inferior aspect of the mesh were dissected, all segment of composite mesh extended to below the umbilicus at the midline was excised, placement of bard mesh, bowel resection, bowel was teased off of the mesh and the abdominal wall, repair of serosal tears, removal of previous mesh, placement of new covidien permacol mesh, drainage of intrabdominal abscess as well as three areas of small bowel required resection: part that had leaked, torn during lysis of adhesions, ct-scan, medication, use of drains, and was devascularized from tearing and having bleeding.Relevant tests/laboratory data b6: 10 dec 2011: op note stated ct scan demonstrated free fluid and contrast extravasating from the bowel.
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Manufacturer Narrative
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Additional information: b5, b7, d8, e1(street 1, city, region, postal code), g1(manufacturer name, first name, last name, street 1, city, region, postal code, email, phone), h6(patient codes, device 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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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 laparoscopic therapeutic treatment of a recurrent ventral hernia.It was reported that after implant, the patient experienced recurrence, extensive adhesions, serosal tears, abscess in left lateral abdominal area, leakage, bleeding, infection, and peritonitis, a perforation from a surgical complication, partial dehiscence of mesh, mesh division, purulent material.Post-operative patient treatment included recurrent incisional hernia repair with new bard mesh, omentum and small bowel attached to the inferior aspect of the mesh were dissected, all segment of composite mesh extended to below the umbilicus at the midline was excised, placement of bard mesh, bowel resection, bowel was teased off of the mesh and the abdominal wall, repair of serosal tears, removal of previous mesh, placement of new covidien permacol mesh, sutures removed, reinforcement of mesh, drainage of intrabdominal abscess as well as three areas of small bowel required resection: part that had leaked, torn during lysis of adhesions, ct-scan, medication, use of drains, and was devascularized from tearing and having bleeding.
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Manufacturer Narrative
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Additional info: b5, b6, b7, h6 (patient device 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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