FDA Adverse Event
Injury
Summary report: N
LAMITRODE TRIPOLE 16
MDR report key: 2921595
·
Received January 10, 2013
Report
- Report Number
- 1627487-2013-03105
- Event Type
- Injury
- Date Received
- January 10, 2013
- Date of Event
- December 12, 2012
- Report Date
- December 19, 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 EXPERIENCED ABDOMINAL PAIN IN ADDITION TO NUMBNESS FROM HER LEG TO HER TOES. FOLLOW-UP IDENTIFIED THE PATIENT'S ABDOMINAL PAIN AND NUMBNESS HAS IMPROVED; THE ABDOMINAL PAIN IS "ALMOST GONE" AND CURRENTLY THE PATIENT IS ONLY EXPERIENCING NUMBNESS IN TWO OF HER TOES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 15512 | LAMITRODE TRIPOLE 16 | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3219 | 3717046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention | SCS IPG: MODEL 3788| IMPLANT DATE: |