FDA Adverse Event
Death
Summary report: N
LAMITRODE TRIPOLE 16 LEAD, 60 CM
MDR report key: 2023194
·
Received March 16, 2011
Report
- Report Number
- 1627487-2011-00361
- Event Type
- Death
- Date Received
- March 16, 2011
- Date of Event
- February 14, 2011
- Report Date
- February 14, 2011
- Manufacturer
- ST JUDE MEDICAL - NEUROMODULATION DIVISION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 2 OF 2. REFERENCE MFR REPORT #1627487-2011-00350.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAMITRODE TRIPOLE 16 LEAD, 60 CM | SPINAL CORD STIMULATION LEAD | LGW | ST JUDE MEDICAL - NEUROMODULATION DIVISION | 3219 | 3094246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Death |