FDA Adverse Event
Malfunction
Summary report: N
TENDRIL STS
MDR report key: 4231270
·
Received November 6, 2014
Report
- Report Number
- 2017865-2014-18088
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- August 27, 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
- 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 NOISE HAD BEEN OBSERVED ON THE RIGHT VENTRICULAR LEAD OF AN ASYMPTOMATIC PATIENT. THE LEADS PACING CONFIGURATION WAS CHANGED AND THE PATIENT WOULD CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714228 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | (B)(4) |