FDA Adverse Event
Death
Summary report: N
ENRHYTHM DR
MDR report key: 1935371
·
Received December 22, 2010
Report
- Report Number
- 2647346-2010-00950
- Event Type
- Death
- Date Received
- December 22, 2010
- Date of Event
- October 27, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S38
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS NOTED THE PATIENT DIED APPROXIMATELY 10 MONTHS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.
Description of Event or Problem · 1
IT WAS NOTED THE PATIENT DIED APPROXIMATELY 10 MONTHS AFTER DEVICE IMPLANT. FOLLOW UP LATER REVEALED THE CAUSE OF DEATH WAS RIGHT MIDDLE CEREBROVASCULAR ACCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENRHYTHM DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | P1501DR | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Death |