FDA Adverse Event
Injury
Summary report: N
LAMITRODE 44C
MDR report key: 2893134
·
Received December 28, 2012
Report
- Report Number
- 1627487-2012-13290
- Event Type
- Injury
- Date Received
- December 28, 2012
- Date of Event
- December 3, 2012
- Report Date
- December 3, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- 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
IT WAS REPORTED, THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION FROM HER SCS SYSTEM. THE IMPLANTED LEAD WAS FUNCTIONAL, HOWEVER, THE PHYSICIAN OPTED TO REPLACE THE LEAD IN ORDER TO ACHIEVE BETTER STIMULATION COVERAGE. THE PT WAS REPROGRAMMED AND IS NOW RECEIVING EFFECTIVE STIMULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAMITRODE 44C | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3245 | 37360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | SCS IPG: MODEL: 3788| IMPLANT DATE: |