FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1010879
·
Received March 10, 2008
Report
- Report Number
- 2017865-2008-00920
- Event Type
- Injury
- Date Received
- March 10, 2008
- Date of Event
- October 30, 2009
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT ALL FIVE WIRES OF THE PROXIMAL COIL WERE FRACTURED AT 27.5 CM FROM THE CONNECTOR PIN, DUE TO CLAVICULAR CRUSH, WHICH CAUSED THE REPORTED NOISE. THE PROXIMAL AND DISTAL INSULATIONS WERE DAMAGED THROUGH TO THE COIL IN THE SAME AREA.
Description of Event or Problem · 1
THE ATRIAL LEAD WAS REPLACED DUE TO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) -FIRED TWICE-.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1688TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |