FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 2013896
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01574
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- December 23, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT THE PROXIMAL AND DISTAL INSULATIONS WERE ABRADED AND ALL FIVE WIRES OF THE PROXIMAL COIL WERE FRACTURED AT 27 CM FROM THE CONNECTOR PIN, DUE TO CLAVICULAR CRUSH.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CHEST X-RAY REVEALED CLAVICULAR CRUSH DAMAGE TO THE LEAD. WHEN THE POCKET WAS OPENED, THERE WAS A VISIBLE INSULATION TEAR. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1888TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |