FDA Adverse Event
Injury
Summary report: N
LAMITRODE TRIPOLE 16
MDR report key: 3962508
·
Received July 14, 2014
Report
- Report Number
- 1627487-2014-25512
- Event Type
- Injury
- Date Received
- July 14, 2014
- Date of Event
- May 22, 2014
- Report Date
- June 25, 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
DEVICE 2 OF 2. REF MFR REPORT#1627487-2014-25442.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409535 | LAMITRODE TRIPOLE 16 | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3219 | 3595404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |