FDA Adverse Event
Death
Summary report: N
EON
MDR report key: 2980808
·
Received February 22, 2013
Report
- Report Number
- 1627487-2013-04229
- Event Type
- Death
- Date Received
- February 22, 2013
- Date of Event
- January 17, 2013
- Report Date
- January 31, 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 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 PT HAD STIMULATION, BUT THE PT WANTED A NEW CHARGING SYSTEM. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT. FOLLOW UP REGARDING THE CHARGING SYSTEM FOUND THE PT HAD DIED. THE FAMILY MEMBER REC'D A POSTCARD REMINDER AND CONTACTED THE SJM REP NOTIFYING OF THE DEATH. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78386 | EON | SCS IPG | LGW | ST JUDE MEDICAL - NEUROMODULATION | 3716 | 173913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death | SCS LEAD: MODEL 3186| IMPLANT DATE: |