FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 3926184
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15492
- Event Type
- Malfunction
- Date Received
- July 10, 2014
- Date of Event
- May 21, 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
- PA, US
- Reporter Occupation
- NURSE
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 ATRIAL LEAD EXHIBITED NOISE. THE NOISE WAS REPRODUCIBLE THROUGH EXTREME UPPER BODY ISOMETRICS. DURING TESTING, THE LEAD ALSO EXHIBITED LOW IMPEDANCE. THE DEVICE WAS REPROGRAMMED AND THE PATIENT WOULD CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 402713 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1688TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |