FDA Adverse Event
Injury
Summary report: N
ACTICON NEOSPHINCTER
MDR report key: 2070979
·
Received April 19, 2011
Report
- Report Number
- 2183959-2011-00140
- Event Type
- Injury
- Date Received
- April 19, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 23, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- MIP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS SURGERY, IT WILL BE REEVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
ON (B)(6) 2010, AN ACTICON NEOSPHINCTER DEVICE WAS IMPLANTED. REVISION SURGERY ON (B)(6) 2011, DUE TO "BALLOON MIGRATION." THE DETAILS OF THE PATIENT'S PRESENT CONDITION AND WHAT OCCURRED AT THIS SURGERY WERE NOT INDICATED. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTICON NEOSPHINCTER | ARTIFICIAL BOWEL SPHINCTER | MIP | AMERICAN MEDICAL SYSTEMS, INC. | ABS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization| R |