|
Model Number PCO1510X |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
|
Patient Problems
Adhesion(s) (1695); Failure of Implant (1924); Pain (1994); Hernia (2240); Anxiety (2328); Injury (2348); Depression (2361); Abdominal Distention (2601); No Code Available (3191); Unspecified Tissue Injury (4559)
|
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
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 extensive lysis of adhesions, mesh adherent to bowel, mesh removal and recurrent hernia.After treatment, the patient experienced mesh removal.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia in a laparoscopic procedure that was converted to open repair.It was reported that after a procedure where this device was implanted, the patient experienced extensive lysis of adhesions, mesh adherent to bowel, mesh removal, and recurrent hernia.After treatment, the patient experienced mesh removal.The device had been used with an unknown absorbable tacker.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced adhesions, mesh adherent to bowel, pain, and recurrence.Post-operative patient treatment included revision surgery, lysis of adhesions, and mesh removal.
|
|
Manufacturer Narrative
|
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: a4(weight in lbs), b5, b7, d11, g4 corrected information: d6 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.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after a procedure where this device was implanted, the patient experienced adhesions, mesh adherent to bowel, and recurrence.After treatment, the patient experienced revision surgery, lysis of adhesions, and mesh removal.The device had been used with an unknown absorbable tacker.
|
|
Manufacturer Narrative
|
Additional information: b5, b7, g1 (manufacturer name, first name, last name, street 1, city, region, postal code, email, phone), h6 (patient 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.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced adhesions, mesh adherent to bowel, pain, digestive issues, bloating, depression, anxiety, and recurrence.Post-operative patient treatment included medication, revision surgery, lysis of adhesions, mesh removal., and hernia repair with new mesh.Concomitant device: unknown absorbable tacker.
|
|
Search Alerts/Recalls
|
|
|