FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2081043
·
Received April 14, 2011
Report
- Report Number
- 3004209178-2011-02825
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Report Date
- April 5, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT WENT ON A "VIBRATION PLATFORM" AND FELT "SOME" SHOCKING. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LEAD: MODEL 3093, LOT# V590594| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD113074N| IMPLANTED: |