FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 2983740
·
Received February 28, 2013
Report
- Report Number
- 2017865-2013-01475
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- December 17, 2012
- 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
- NE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT ALL FIVE WIRES OF THE PROXIMAL COIL WERE FRACTURED AT 37.0 CM FROM THE CONNECTOR PIN, DUE TO CLAVICULAR CRUSH. THE DISTAL INSULATION WAS FOUND DAMAGED AT THE SAME AREA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED INTERMITTENT SENSING, HIGH THRESHOLDS AND OVER SENSING DUE TO CLAVICULAR CRUSH DAMAGE. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87774 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1688TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |