FDA Adverse Event
Injury
Summary report: N
LAMITRODE S8
MDR report key: 3022397
·
Received March 22, 2013
Report
- Report Number
- 1627487-2013-06084
- Event Type
- Injury
- Date Received
- March 22, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 28, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-06085. THE PT HAS TWO LEADS FROM DIFFERENT LOTS FOR RIGHT AND LEFT LEG PAIN. IT WAS REPORTED THAT THE PT STATES SHE HAS LOST STIMULATION IN HER RIGHT LEG. SJM REP MET WITH THE PT AND REPROGRAMMED THE PT'S SYSTEM. THE PT NOW FEELS STIMULATION IN BOTH LEGS BUT SHE STATED SHE FEELS IT MORE IN THE LEFT LEG. THE SJM REP PLANS TO MEET WITH THE PT AT HER NEXT F/U APPOINTMENT AND DETERMINE IF OTHER INTERVENTION IS NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 119534 | LAMITRODE S8 | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3286 | 3456429 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192(X2)| IMPLANT DATE:| IMPLANT DATE: |