FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 1073433
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02217
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 6, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND THAT TOO MANY REVOLUTIONS HAD BEEN APPLIED WHILE EXTENDING THE HELIX, CAUSING OVER TORQUE OF THE DISTAL COIL. THIS RESULTED IN THE DISTAL COIL COLLAPSING, WHICH DAMAGED THE DISTAL INSULATION AND CAUSED THE LEAD COILS TO SHORT CIRCUIT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED LOW SENSING, HIGH CAPTURE THRESHOLDS, AND IMPEDANCE OF LESS THAN 200 OHMS. THE LEAD WAS 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 | 1788TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |