FDA Adverse Event
Injury
Summary report: N
LAMITRODE TRIPOLE 16C
MDR report key: 3123549
·
Received May 17, 2013
Report
- Report Number
- 1627487-2013-15652
- Event Type
- Injury
- Date Received
- May 17, 2013
- Date of Event
- June 4, 2012
- Report Date
- June 4, 2012
- 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 WAS WITHOUT STIMULATION. X-RAYS WERE TAKEN AND SHOWED THE LEAD HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN IN (B)(6) 2012 AND THE LEAD WAS REPOSITIONED. THE PATIENT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 219173 | LAMITRODE TRIPOLE 16C | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3214 | 3255437 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention | IMPLANT:| IMPLANT:| SCS IPG: MODEL 3788| SCS EXTENSION: MODEL 3386 (2) |