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Model Number PCO15X |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abdominal Pain (1685); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Necrosis (1971); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: abstack30 abs fixation device 30 tacks (lot# n6b0379emx).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 ventral hernia.It was reported that after the implant, the patient experienced an unspecified adverse outcome.Post-operative patient treatment included revision surgery and removal of mesh.
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Manufacturer Narrative
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Additional information: b5, b6, g4, 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 a ventral hernia.It was reported that after the implant, the patient experienced recurrence, abdominal pain, hemorrhagic changes, necrosis, and ischemia.Post-operative patient treatment included revision surgery, removal of mesh, hernia repair with new mesh, and small bowel resection.
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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 ventral hernia.It was reported that after the implant, the patient experienced recurrence.Post-operative patient treatment included revision surgery, removal of mesh, hernia repair with new mesh, and small bowel resection.
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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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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 ventral hernia.It was reported that after the implant, the patient experienced recurrence, abdominal pain, hemorrhagic changes, necrosis, infection, pain, inflammation, scarification, mesh encapsulation, lack of adequate ingrowth, and ischemia.Post-operative patient treatment included revision surgery, removal of mesh, hernia repair with new mesh, and small bowel resection.
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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 ventral hernia.It was reported that after the implant, the patient experienced recurrence, abdominal pain, hemorrhagic changes, necrosis, infection, pain, inflammation, scarification, mesh encapsulation, lack of adequate ingrowth, obstruction, and ischemia.Post-operative patient treatment included revision surgery, removal of mesh, hernia repair with new mesh, ct-scan, medication, and small bowel resection.Relevant tests/laboratory data: (b)(6) 2017: op note stated ct findings suggested the possibility of associated strangulation and ischemic bowel.
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Search Alerts/Recalls
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