FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX LEAD
MDR report key: 6042753
·
Received October 19, 2016
Report
- Report Number
- 2938836-2016-13038
- Event Type
- Malfunction
- Date Received
- October 19, 2016
- Date of Event
- September 9, 2016
- Report Date
- September 9, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IN-HOSPITAL DEVICE CHECK, NOISE WAS OBSERVED ON THE ATRIAL LEAD. ATRIAL LEAD NOISE FOUND TO HAVE CAUSED AUTO MODE SWITCH EPISODES AND VENTRICULAR TRACKING OF NOISE. NO OTHER FINDINGS ATTRIBUTABLE TO LEAD NOISE NOTED DURING INTERROGATION. THE PATIENT'S CONDITION IS STABLE. DEVICE REPROGRAMMING WAS MADE. NO FURTHER INTERVENTION REGARDING ATRIAL LEAD IS PLANNED AT THIS TIME. PATIENT WILL CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 690874 | TENDRIL SDX LEAD | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 1488T/52 | 0002390921 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |