FDA Adverse Event
Injury
Summary report: N
LAMITRODE TRIPOLE 16C
MDR report key: 3223246
·
Received July 10, 2013
Report
- Report Number
- 1627487-2013-06593
- Event Type
- Injury
- Date Received
- July 10, 2013
- Date of Event
- June 14, 2013
- Report Date
- June 14, 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 HAD HER SCS SYSTEM REMOVED BECAUSE SHE WAS NOT RECEIVING EFFECTIVE STIMULATION THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317685 | LAMITRODE TRIPOLE 16C | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3214 | 116801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other | IMPLANT DATE:| SCS IPG: MODEL 3716 |