FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 1073481
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02260
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- February 7, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- OR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED NO CAPTURE IN UNIPOLAR AND THRESHOLDS OF 7 V, 1.5 MS IN THE BIPOLAR CONFIGURATION. IN FEBRUARY 2008 CAPTURE THRESHOLDS WERE 6.5 V, 1.5 MS IN UNIPOLAR AND 7.5 V, 1.5 MS IN THE BIPOLAR CONFIGURATION. THE PATIENT WAS PACED LESS THAN ONE PERCENT IN THE VENTRICLE. THE PATIENT WAS NOT PACEMAKER DEPENDENT AND WOULD BE MONITORED.
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 | 1488T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |