FDA Adverse Event
Malfunction
Summary report: N
TENDRIL ST
MDR report key: 2083665
·
Received May 10, 2011
Report
- Report Number
- 2017865-2011-02897
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- December 17, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS REPORT IS LATE DUE TO AN ADMINISTRATIVE ERROR. RELIABILITY LABORATORY TECHNICIAN, (B)(4) FAILURE (EVENT) OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND MEDICAL ADHESIVE ON THE RING ELECTRODE, CAUSING THE LEAD TO EXHIBIT HIGH THRESHOLDS.
Description of Event or Problem · 1
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1888TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |