FDA Adverse Event
Malfunction
Summary report: N
TENDRIL ST
MDR report key: 2083667
·
Received May 10, 2011
Report
- Report Number
- 2017865-2011-02901
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- March 11, 2011
- 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. RELIABILITY LABORATORY TECHNICIAN, NOT APPLICABLE. (B)(4) FAILURE (EVENT) OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND MEDICAL ADHESIVE ON THE RING ELECTRODE, CAUSING THE LEAD TO EXHIBIT HIGH IMPEDANCE AND HIGH CAPTURE 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 |