FDA Adverse Event
Death
Summary report: N
TENDRIL ST
MDR report key: 3090508
·
Received May 2, 2013
Report
- Report Number
- 2017865-2013-01739
- Event Type
- Death
- Date Received
- May 2, 2013
- Date of Event
- April 17, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION FROM THE FIELD NOTES THE PATIENT'S DEATH WAS NOT DEVICE RELATED. THE PATIENT WAS ADMITTED TO HOSPICE HOUSE AND THE DEVICE WAS TURNED OFF.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE WAS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT SUGGESTS THE DEATH WAS DEVICE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192699 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1888TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death | (B)(4), GUIDANT: (B)(4) |