FDA Adverse Event
Death
Summary report: N
QUARTET
MDR report key: 3791345
·
Received May 5, 2014
Report
- Report Number
- 2017865-2014-12002
- Event Type
- Death
- Date Received
- May 5, 2014
- Date of Event
- April 27, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- OJX
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION PROVIDED WAS THAT THE PATIENT HAD ELECTED TO BE IN HOSPICE CARE. THE PATIENTS DEATH WAS CONFIRMED NOT TO BE DEVICE RELATED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267140 | QUARTET | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC., CRMD | 1458Q/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Death | 3249,70194602088,CAU0931777122,BKB030582 |