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Model Number PCO12X |
Device Problems
Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Seroma (2069); Vomiting (2144); Discharge (2225); Excessive Tear Production (2235); Hernia (2240); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); 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 therapeutic treatment of incisional ventral hernia.It was reported that after implant, the patient experienced recurrence, serosal rents, adhesions, and mesh erosion into viscera.Post-operative patient treatment included revision surgeries, repair of hernia with mesh, repair of serosal rents, and adhesions dissected off mesh.
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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 incisional ventral hernia.It was reported that after implant, the patient experienced recurrence, pain, tenderness, nausea, vomiting, abdominal pain, serosal rents, bacterial infection, abdominal drainage, adhesions, and mesh erosion into viscera.Post-operative patient treatment included revision surgeries, repair of hernia with mesh, lap cholecystectomy, repair of serosal rents, antibiotics, and adhesions dissected off mesh.The device was used with an unknown absorbable tacker.
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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 incisional ventral hernia.It was reported that after implant, the patient experienced recurrence, pain, tenderness, nausea, vomiting, abdominal pain, serosal rents, bacterial infection, abdominal drainage, adhesions, small bowel obstruction, hematoma, small bowel stuck up to mesh/through the fascia, incarcerated hernia, and mesh erosion into viscera.Post-operative patient treatment included revision surgeries, repair of hernia with mesh, lap cholecystectomy, repair of serosal rents, antibiotics, and adhesions dissected off 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.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 incisional ventral hernia.It was reported that after implant, the patient experienced inflammation, adhesions, bleeding, seroma, serosal tear, leakage from umbilicus, recurrence, pain, tenderness, nausea, vomiting, abdominal pain, serosal rents, bacterial infection, abdominal drainage, adhesions, small bowel obstruction, hematoma, small bowel stuck up to mesh/through the fascia, incarcerated hernia, and mesh erosion into viscera.Post-operative patient treatment included revision surgeries, repair of hernia with mesh, lap cholecystectomy, repair of serosal rents, antibiotics, lysis of adhesions, ct-scan, and adhesions dissected off mesh.Relevant tests/laboratory data, including dates (b7) (b)(6) 2015: ct scan in ed that showed what appeared to be a loop of small bowel stuck up through the fascia.Repeat ct scan same day showed no change.
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Search Alerts/Recalls
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