FDA Adverse Event
Malfunction
Summary report: N
TENDRIL ST
MDR report key: 3923341
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14631
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- April 22, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE. AFTER A LEAD REVISION FOR THE RIGHT VENTRICULAR LEAD, THE ANOMALY WAS NO LONGER NOTED. THE ATRIAL LEAD REMAINED IMPLANTED. THE PATIENT WAS ASYMPTOMATIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401755 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1888TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | (B)(4) |