FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 3923941
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14929
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- February 24, 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
- CA, 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 RIGHT VENTRICLE LEAD EXHIBITED NOISE AND LOW IMPEDANCES. UPON LEAD REVISION, AN INSULATION ANOMALY WAS NOTED ON THE LEAD. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401763 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |