FDA Adverse Event
Injury
Summary report: N
LAMITRODE TRIPOLE 16C
MDR report key: 3032254
·
Received March 29, 2013
Report
- Report Number
- 1627487-2013-03433
- Event Type
- Injury
- Date Received
- March 29, 2013
- Date of Event
- March 4, 2013
- Report Date
- March 4, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- 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 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
IT WAS REPORTED THE PATIENT WANTS HER SCS SYSTEM EXPLANTED DUE TO NO LONGER RECEIVING EFFECTIVE STIMULATION AS HER PAIN MOVES THROUGHOUT HER BODY AND IS UNPREDICTABLE. FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 130520 | LAMITRODE TRIPOLE 16C | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3214 | 3627398 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention | IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR, MODEL 1192| SCS IPG, MODEL 3716 |