FDA Adverse Event
Injury
Summary report: N
LAMITRODE TRIPOLE 16
MDR report key: 2843434
·
Received November 15, 2012
Report
- Report Number
- 1627487-2012-12507
- Event Type
- Injury
- Date Received
- November 15, 2012
- Date of Event
- October 22, 2012
- Report Date
- October 26, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- 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 OVERSTIMULATED BY THE SYSTEM AND EXPERIENCED INTENSE RIB STIMULATION. REPORTEDLY THE PATIENT WAS ABLE TO TURN OFF THE STIMULATION. IT WAS ALSO REPORTED THE PATIENT TURNED ON STIMULATION USING THE PROGRAMMER, WHICH INCREASED STIMULATION AMPLITUDE ON ITS OWN. FOLLOW-UP REVEALED THE SJM REPRESENTATIVE REPROGRAMMED TO REGAIN COVERAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAMITRODE TRIPOLE 16 | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3219 | 2745756 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention | SCS IPG: MODEL 3788| IMPLANT: |