FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1955807
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00819
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 12, 2010
- 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AS RECEIVED THE LEAD WAS CUT INTO FIVE PIECES. THE DAMAGE WAS FOUND CONSISTENT WITH THAT OCCURRING AT THE TIME OF EXPLANT. FINAL ANALYSIS FOUND THAT THE PROXIMAL INSULATION WAS CRUSHED AND THE PROIXMAL COIL WAS DAMAGED, AT TWO ENDS OF THE CENTER PIECES. ONE OF THE FILARS OF THE DAMAGED COIL WAS MELTED AT THE TIP. ALL FIVE FILARS OF THE COIL WERE FRACTURED, DUE TO CLAVICULAR CRUSH.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : NA.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CHEST X-RAY REVEALED ATRIAL LEAD INSULATION DAMAGE IN THE AREA UNDER THE COLLAR-BONE. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1688TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention | (B)(4) |