FDA Adverse Event
Injury
Summary report: N
LAMITRODE TRIPOLE 16 LEAD, 60 CM
MDR report key: 2033437
·
Received March 24, 2011
Report
- Report Number
- 1627487-2011-00411
- Event Type
- Injury
- Date Received
- March 24, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 2011
- Manufacturer
- ST JUDE MEDICAL- NEUROMODULATION DIVISION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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
IT WAS REPORTED THAT THE PT HAS REQUESTED THAT HER SCS SYSTEM BE REMOVED FOR FEAR ITS USE MAY TRIGGER A CEREBROVASCULAR EVENT. A DATE FOR THE PROCEDURE HAS NOT BEEN SET. REFERENCE MFR REPORT # 1627487-2010-01430.
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 | 2881381 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization| R |