FDA Adverse Event
Death
Summary report: N
CARDIO PACEMAKER
MDR report key: 17469495
·
Received August 4, 2023
Report
- Report Number
- MW5120626
- Event Type
- Death
- Date Received
- August 4, 2023
- Date of Event
- February 1, 2021
- Report Date
- August 2, 2023
- Manufacturer
- UNK
- Product Code
- DXY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- Health Professional
- *
Narratives
Description of Event or Problem · 0
I HAD A BROTHER WHO WAS IMPLANTED WITH A CARDIAC RHYTHM STIMULATION DEVICE. IT STARTED TO MALFUNCTION AND HE SLUMPED TO NEAR DEATH AROUND 4PM. HE DIED WHILE WAITING TO GET TO HOSPITAL. HE WAS A DEPARTMENT OF VETERANS AFFAIRS PATIENT AND VIETNAM ERA MARINE. MY NAME (B)(6). TODAY IS 08/02/2023. I'M FILING CIVIL ACTION IN COURTS FOR DAMAGES FROM KNOWN DAMNUM. FDA/MEDICAL CENTER/MANUFACTURER SINCE 2005 AND EVEN NOW 2023. DAMAGES INCLUDE EXEMPLARY AND PUNITIVE DAMAGES. THANK YOU VERY MUCH, (B)(6), COMPLAINANT. AUGUST 2, 2023. (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2335517 | CARDIO PACEMAKER | IMPLANTABLE PACEMAKER PULSE-GENERATOR | DXY | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Hospitalization| S| D| L| R |