FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1924785
·
Received December 7, 2010
Report
- Report Number
- 3004209178-2010-10267
- Event Type
- Injury
- Date Received
- December 7, 2010
- Date of Event
- November 30, 2010
- Report Date
- November 30, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUCNOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NEUROSTIMULATOR WAS NOT EFFECTIVE ANY LONGER FOR THE PT. THE LEAD WAS TESTED INTRA-OPERATIVELY AND FOUND TO BE OKAY. THEREFORE, THE STIMULATOR WAS REPLACED. THERE WERE NO PT INJURIES AND THE PT WAS REPORTED AS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MDT PUERTO RICO OPERATIONS CO., JUCNOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |