FDA Adverse Event
Injury
Summary report: N
LAMITRODE S8
MDR report key: 2894878
·
Received December 20, 2012
Report
- Report Number
- 1627487-2012-11880
- Event Type
- Injury
- Date Received
- December 20, 2012
- Date of Event
- November 30, 2012
- Report Date
- November 30, 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
DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-11879. IT WAS REPORTED ONE OF THE LEADS HAD MIGRATED, AND THE PHYSICIAN REPOSITIONED AND ANCHORED THE LEAD. IT WAS UNDETERMINED WHICH LEAD WAS REPOSITIONED, SO BOTH WILL BE REPORTED. IT WAS REPORTED THE PT RECEIVED EFFECTIVE STIMULATION POSTOPERATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAMITRODE S8 | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3286 | 3467812 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | SCS IPG: MODEL 3788| IMPLANT: |