FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 3926058
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15399
- Event Type
- Injury
- Date Received
- July 10, 2014
- Date of Event
- May 29, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, 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 EXPERIENCED SYNCOPE AND PRESENTED IN THE EMERGENCY ROOM. THE RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE AND UNACCEPTABLE THRESHOLDS. THE LEAD WAS DISLODGED. THE PATIENT WENT ASYSTOLIC WHILE IN THE EMERGENCY ROOM AND EXTERNAL PACING PATCHES WERE APPLIED. SUBSEQUENTLY, A TEMPORARY PACING WIRE WAS PLACED IN THE NECK. THE LEAD WAS SUCCESSFULLY REPOSITIONED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 403365 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |