FDA Adverse Event
Death
Summary report: N
QUARTET
MDR report key: 6061505
·
Received October 27, 2016
Report
- Report Number
- 2938836-2016-13369
- Event Type
- Death
- Date Received
- October 27, 2016
- Date of Event
- August 27, 2016
- Report Date
- September 29, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- OJX
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WITH THE LEAD TIP MEASURING 7.2CM WAS RETURNED FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL.
Description of Event or Problem · 1
T WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. THE CAUSE OF DEATH ON DEATH CERTIFICATE NOTES CONGESTIVE HEART FAILURE. THE MANNER OF DEATH WAS NATURAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 711580 | QUARTET | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 1458Q/86 | 3665366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 94 YR | Death | (B)(4)| (B)(4)| (B)(4) |