FDA Adverse Event
Injury
Summary report: N
LAMITRODE TRIPOLE 16
MDR report key: 4180135
·
Received October 15, 2014
Report
- Report Number
- 1627487-2014-05706
- Event Type
- Injury
- Date Received
- October 15, 2014
- Date of Event
- September 20, 2010
- Report Date
- September 24, 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
(B)(4). 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 PLANS TO UNDERGO SURGICAL INTERVENTION DUE TO NEVER RECEIVING EFFECTIVE STIMULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653974 | LAMITRODE TRIPOLE 16 | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3219 | 316521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other | IMPLANT DATE| SCS IPG: MODEL - 3788 |