FDA Adverse Event
Death
Summary report: N
INTERSTIM
MDR report key: 1150601
·
Received September 5, 2008
Report
- Report Number
- 3004209178-2008-05458
- Event Type
- Death
- Date Received
- September 5, 2008
- Date of Event
- April 15, 2008
- Report Date
- August 5, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPIRED IN 2008. AN INQUIRY WAS MADE AT THE TIME OF THE REPORT AS TO HOW TO DONATE THE PT'S PROGRAMMER. NO CAUSE OF DEATH WAS PROVIDED BUT IT WAS DESCRIBED AS UNRELATED TO THE DEVICE. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE AND THE HOSP YIELDED NO INFO. CAUSE OF DEATH REMAINS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Death | EXPLANTED| LEAD MODEL 3889 LOT# V000521| EXTENSION MODEL 3095 LOT# NAH026254V| EXPLANTED| IMPLANTED| PROGRAMMER MODEL 3031A LOT# NGM024872P| IMPLANTED |