FDA Adverse Event
Death
Summary report: N
ZEPHYR XL DR
MDR report key: 4950561
·
Received July 29, 2015
Report
- Report Number
- 2017865-2015-27295
- Event Type
- Death
- Date Received
- July 29, 2015
- Date of Event
- September 24, 2014
- Report Date
- July 17, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- LWP
- PMA / PMN Number
- P880086
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
NEW INFORMATION REPORTED STATED THAT THE PATIENT'S CAUSE OF DEATH WAS CARDIOVASCULAR DISEASE AND PNEUMONIA.
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 ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 493567 | ZEPHYR XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 5826 | 3209513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Death | (B)(4) |