FDA Adverse Event
Malfunction
Summary report: N
TENDRIL STS
MDR report key: 10853558
·
Received November 17, 2020
Report
- Report Number
- 2017865-2020-16836
- Event Type
- Malfunction
- Date Received
- November 17, 2020
- Date of Event
- October 28, 2020
- Report Date
- November 17, 2020
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- UDI-DI
- 05414734502887
- PMA / PMN Number
- P960013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT IS REGISTERED AS A COMBINATION PRODUCT. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem · 1
RELATED MANUFACTURER REFERENCE 2017865-2020-16837. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS EXHIBITED NOISE. NOISE COULD NOT BE REPRODUCED WITH ISOMETRICS IN THE CLINIC. NO INTERVENTION WAS PERFORMED; THE PHYSICIAN ATTRIBUTED THE NOISE TO AN EXTERNAL SOURCE. THE PATIENT WAS STABLE THROUGHOUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1318955 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 2088TC/52 | 4424853 | 05414734502887 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | TENDRIL STS |