FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1983069
·
Received February 4, 2011
Report
- Report Number
- 3004209178-2011-00882
- Event Type
- Injury
- Date Received
- February 4, 2011
- Date of Event
- May 12, 2010
- Report Date
- January 26, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED "MASSIVE WEIGHT LOSS" FROM GASTRIC BYPASS SURGERY. SUBSEQUENTLY, THE DEVICE SYSTEM WAS EXPLANTED AS IT BECAME UNCOMFORTABLE. SEE MFG REPORT # 3004209178-2011-00555 FOR SUBSEQUENT REPLACEMENT NEUROSTIMULATOR ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention | EXTENSION: MODEL 3095, LOT# NAH023926V| EXPLANTED:| LEAD: MODEL 3889, LOT# J0546423V| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM022222P| IMPLANTED: |