FDA Adverse Event
Injury
Summary report: N
MTS MULTIPROGRAM TRIAL STIMULATOR
MDR report key: 2000766
·
Received February 17, 2011
Report
- Report Number
- 1627487-2011-00233
- Event Type
- Injury
- Date Received
- February 17, 2011
- Date of Event
- January 21, 2011
- Report Date
- January 21, 2011
- Manufacturer
- ST JUDE MEDICAL - NEUROMODULATION DIVISION
- Product Code
- GZB
- PMA / PMN Number
- K033757
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 3 OF 3. REFERENCE MFR. REPORT #S 1627487-2011-00231 AND 1627487-2011-00232.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MTS MULTIPROGRAM TRIAL STIMULATOR | STIMULATOR, SPINAL CORD, IMPLANTED | GZB | ST JUDE MEDICAL - NEUROMODULATION DIVISION | 3510 | 3052203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |