FDA Adverse Event
Death
Summary report: N
MEDTRONIC
MDR report key: 2500919
·
Received March 20, 2012
Report
- Report Number
- MW5024695
- Event Type
- Death
- Date Received
- March 20, 2012
- Manufacturer
- MEDTRONIC
- Product Code
- LWS
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
TO WHOM IT MAY CONCERN: 3 DAYS BEFORE MY HUSBAND DIED, I CALLED THE 1-800 NUMBER AND THE LADY THAT ANSWERED THE PHONE, TOLD ME THAT HIS DEFIBRILLATOR WAS ON RECALL SINCE 2005. NO ONE EVER TOLD US THAT. HE HAD IT PUT IN (B)(6) 2003. HE DIED 2008. COULD YOU PLEASE LET ME KNOW IF IT WAS ON RECALL, THANK YOU. (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC | MARQUIS DR DEFIBRILLATOR | LWS | MEDTRONIC | 7274 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death | IMPLANTED:| SPRINT QUATTRO SECURE: MODEL#: 6947 65,| CAPSUREFIX NOVUS: MODEL#: 507652| SERIAL#: (B)(4)| IMPLANTED:| SERIAL#: (B)(4) |