FDA Adverse Event
Malfunction
Summary report: N
TENDRIL ST
MDR report key: 3923353
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14643
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- April 4, 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
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 VENTRICULAR LEAD EXHIBITED NOISE; MULTIPLE NOISE REVERSION EPISODES WERE RECORDED. THE NOISE COULD NOT BE REPRODUCED WITH PROVOCATIVE ARM MOVEMENT OR POCKET MANIPULATION. THE LEAD REMAINED IMPLANTED AND THE PATIENT WOULD CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401759 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1888TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |