FDA Adverse Event
Injury
Summary report: N
LAMITRODE TRIPOLE 16
MDR report key: 2894851
·
Received December 20, 2012
Report
- Report Number
- 1627487-2012-03913
- Event Type
- Injury
- Date Received
- December 20, 2012
- Date of Event
- November 28, 2012
- Report Date
- November 28, 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 AFTER THE PATIENT'S PERMANENT IMPLANT PROCEDURE, THE PATIENT IS NOT RECEIVING STIMULATION IN HER COMPLETE PAIN PATTERN DUE TO HAVING SCOLIOSIS WHICH CAUSES THE SCS LEAD TO DRIFT TO THE RIGHT. A SJM REPRESENTATIVE WAS UNABLE TO RESOLVE THE ISSUE WITH PROGRAMMING. FOLLOW-UP IDENTIFIED PER THE SJM REPRESENTATIVE, AS THE PATIENT HEALS THERE IS A POSSIBILITY THAT STIMULATION WILL BE GAINED IN THE REST OF THE PATIENT'S PAIN PATTERN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAMITRODE TRIPOLE 16 | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3219 | 3757220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | SCS IPG: MODEL 3788| IMPLANT: |