FDA Adverse Event
Injury
Summary report: N
EXCLAIM 8
MDR report key: 2890863
·
Received December 21, 2012
Report
- Report Number
- 1627487-2012-15110
- Event Type
- Injury
- Date Received
- December 21, 2012
- Date of Event
- December 3, 2012
- Report Date
- December 3, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-15109. IT WAS REPORTED THE PT WAS NOT RECEIVING ADEQUATE STIMULATION. SURGICAL INTERVENTION WAS SCHEDULED TO BE TAKEN TO ADDRESS THIS ISSUE. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXCLAIM 8 | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3601633 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention | IMPLANTED:| SCS IPG: MODEL 3716 |