FDA Adverse Event
Death
Summary report: N
EONC
MDR report key: 3052201
·
Received April 2, 2013
Report
- Report Number
- 1627487-2013-15438
- Event Type
- Death
- Date Received
- April 2, 2013
- Date of Event
- February 5, 2013
- Report Date
- March 11, 2013
- Manufacturer
- ST JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- 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 INFO 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 PT PASSES AWAY ON (B)(6) 2013. THE CAUSE OF DEATH IS CURRENTLY UNK. F/U IS IN PROGRESS TO OBTAIN ADD'L INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133713 | EONC | SCS IPG | LGW | ST JUDE MEDICAL - NEUROMODULATION | 3688 | 3538823 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Death | SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2) |