FDA Adverse Event
Death
Summary report: N
TENDRIL STS
MDR report key: 5348233
·
Received January 6, 2016
Report
- Report Number
- 2017865-2016-00044
- Event Type
- Death
- Date Received
- January 6, 2016
- Date of Event
- August 30, 2015
- Report Date
- December 11, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DECEASED TWO WEEKS POST THE IMPLANT PROCEDURE. 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.
Description of Event or Problem · 1
NEW INFORMATION WAS REPORTED STATED THAT THE PATIENTS CAUSE OF DEATH WAS DILATED CARDIOMYOPATHY WITH CARDIOGENIC SHOCK; DIABETES MELLITUS AND HYPERTENSION. THE DEATH WAS NOT DEVICE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6162 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 2088TC/52 | P000001904 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | MDT LEN350284V |