FDA Adverse Event
Injury
Summary report: N
QUATTRODE
MDR report key: 2903144
·
Received January 2, 2013
Report
- Report Number
- 1627487-2012-03958
- Event Type
- Injury
- Date Received
- January 2, 2013
- Date of Event
- December 4, 2012
- Report Date
- December 4, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- K072462
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION 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
THE PT RECEIVED 2 OCCIPITAL SCS LEADS (OFF-LABEL) WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT EXPERIENCED UNCOMFORTABLE STIMULATION IN HER RIGHT EAR AND BACK LEFT SIDE OF HER HEAD. A SJM REPRESENTATIVE WAS UNABLE TO RESOLVE THE ISSUE WITH REPROGRAMMING. THE PT IS ALSO NOT RECEIVING OPTIMAL STIMULATION. THE PT IS WORKING WITH THE PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1337 | QUATTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3166 | 3612148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention | IMPLANT DATE:| SCS IPG: MODEL 3716| IMPLANT DATE:| SCS LEAD: MODEL 3169 (2)| IMPLANT DATE:| SCS EXTENSION: MODEL 3346(2) |