FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 2083896
·
Received May 11, 2011
Report
- Report Number
- 2017865-2011-02843
- Event Type
- Injury
- Date Received
- May 11, 2011
- Date of Event
- February 4, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT THE LEAD BODY WAS BENT/KINKED AND THE DISTAL COIL WAS FRACTURED AT 15 CM FROM THE CONNECTOR END WHICH COULD HAVE RESULTED IN NOISE.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE WHICH CAUSED INAPPROPRIATE AUTO MODE SWITCHING. THE NOISE WAS REPRODUCIBLE WITH ISOMETRIC EXERCISES. THE LEAD WAS REMOVED AND REPLACED.
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/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | (B)(4) |