FDA Adverse Event
Death
Summary report: N
EIPG NEURO
MDR report key: 1080719
·
Received July 23, 2008
Report
- Report Number
- 2182207-2008-04297
- Event Type
- Death
- Date Received
- July 23, 2008
- Date of Event
- January 1, 2008
- Report Date
- June 13, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FINAL PROGRAMMER ANALYSIS REVEALED NO ANOMALY FOUND - NORMAL PROGRAMMER FUNCTION.
Description of Event or Problem · 1
IT WAS REPORTED THE PT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. UNABLE TO FOLLOW-UP WITH CONTACT INFO PROVIDED, NO ADDITIONAL INFO WAS OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EIPG NEURO | LGW | MEDTRONIC NEUROMODULATION | IPGNEURO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | LEAD MODEL LEAD LOT# UNK| IMPLANTED:| IMPLANTED:| PROGRAMMER MODEL 7435 LOT# NFT037971P| EXPLANTED:| EXPLANTED:| EXTENSION MODEL EXTENSION LOT# UNK |