FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 2031545
·
Received March 25, 2011
Report
- Report Number
- 3004209178-2011-02141
- Event Type
- Injury
- Date Received
- March 25, 2011
- Report Date
- March 13, 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD THE NEUROSTIMULATOR EXPLANTED AND RE-IMPLANTED "OVER THE YEARS" DUE TO THE DEVICE BEING VERY UNCOMFORTABLE IN THE POCKET AREA. SHE HAS HAD THE DEVICE TURNED OFF FOR "MONTHS." SHE WAS AWAITING EXPLANT AND JUST NEEDED TO CONTACT HER PHYSICIAN. ADDITIONAL INFO WAS REQUESTED.
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 | Required Intervention | IMPLANTED:| LEAD: MODEL 3889, LOT# J0511621V| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH020271V| IMPLANTED: |