FDA Adverse Event
Death
Summary report: N
TENDRIL ST
MDR report key: 3791331
·
Received May 5, 2014
Report
- Report Number
- 2017865-2014-11985
- Event Type
- Death
- Date Received
- May 5, 2014
- Date of Event
- December 23, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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
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.
Description of Event or Problem · 1
ADDITIONAL INFORMATION REPORTED STATED THAT THE DEATH WAS NOT DEVICE OR LEAD RELATED. THE PATIENT DECEASED AT PRESBYTERIAN HOSPITAL IN PHILADELPHIA DUE TO A POST PROCEDURE -TARV- POST OP COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267056 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1888TC/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death | (B)(4), (B)(4) |