FDA Adverse Event
Death
Summary report: N
QUICK FLEX LV LEAD
MDR report key: 4220695
·
Received November 3, 2014
Report
- Report Number
- 2017865-2014-17674
- Event Type
- Death
- Date Received
- November 3, 2014
- Date of Event
- August 29, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- OJX
- PMA / PMN Number
- P030054
- Removal / Correction Number
- Z1483
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
ADDITIONAL INFORMATION REPORTED STATED THAT THE PATIENTS CAUSE OF DEATH WAS RESPIRATORY FAILURE AND LEWY BODY DEMENTIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 701769 | QUICK FLEX LV LEAD | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC., CRMD | 1156T/75 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Death | 3211,577093,7121,(B)(4),4087,162056 |