FDA Adverse Event
Injury
Summary report: N
LAMITRODE 88
MDR report key: 2890818
·
Received December 21, 2012
Report
- Report Number
- 1627487-2012-06987
- Event Type
- Injury
- Date Received
- December 21, 2012
- Report Date
- November 29, 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 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
IT WAS REPORTED, THE PT'S LEAD WAS EXPLANTED AND REPLACED DUE TO INVALID CONTACTS. ON THE DAY OF THE REPLACEMENT PROCEDURE, THE PT INFORMED THE DOCTOR ABOUT BEING IN A CAR ACCIDENT 4 MONTHS PRIOR. IT IS UNK WHEN THE PT BEGAN TO EXPERIENCE INADEQUATE COVERAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAMITRODE 88 | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3288 | 3530279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANT:| SCS IPG: MODEL 3716| SCS ANCHORS: MODEL 1192 (2)| IMPLANT: |