FDA Adverse Event
Injury
Summary report: N
LAMITRODE TRIPOLE 16C
MDR report key: 4132800
·
Received September 29, 2014
Report
- Report Number
- 1627487-2014-01638
- Event Type
- Injury
- Date Received
- September 29, 2014
- Date of Event
- September 2, 2014
- Report Date
- September 9, 2014
- 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 THAT THE PT REQUESTED SURGICAL INTERVENTION DUE TO THE SCS SYSTEM NO LONGER PROVIDING EFFECTIVE NOR SATISFACTORY PAIN RELIEF. IN ADDITION, CONTRAINDICATION TESTING WAS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 606490 | LAMITRODE TRIPOLE 16C | SCS LEAD | GZB | ST JUDE MEDICAL, NEUROMODULATION | 3219 | 3763289 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other | SCS IPG: MODEL 3788,| IMPLANT DATE: |