FDA Adverse Event
Malfunction
Summary report: N
LAMITRODE S8
MDR report key: 2971164
·
Received February 1, 2013
Report
- Report Number
- 1627487-2013-05165
- Event Type
- Malfunction
- Date Received
- February 1, 2013
- Date of Event
- January 11, 2013
- Report Date
- January 11, 2013
- Manufacturer
- ST. JUDE MEDICAL NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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: 1627487-2013-05166. THE PATIENT HAS TWO LEADS (FROM THE SAME LOT). IT WAS REPORTED THE PATIENT IS NOT RECEIVING ADEQUATE COVERAGE. REPROGRAMMING ATTEMPTS HAVE BEEN UNSUCCESSFUL. AN IMPEDANCE CHECK REVEALED NO ANOMALIES. NO FURTHER INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45317 | LAMITRODE S8 | SCS LEAD | LGW | ST. JUDE MEDICAL NEUROMODULATION | 3286 | 3166234 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Required Intervention | SCS ANCHORS: MODEL 1192 (X3)| SCS EXTENSION: MODEL 3343| IMPLANT: |