FDA Adverse Event
Malfunction
Summary report: N
TENDRIL DX
MDR report key: 1073401
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02190
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- May 1, 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
- CA
- 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 ATRIAL LEAD EXHIBITED 200 OHMS IMPEDANCE IN THE UNIPOLAR CONFIGURATION. IN JANUARY, 2005 THE LEAD WAS PROGRAMMED TO UNIPOLAR AFTER THE BIPOLAR IMPEDANCE WAS LESS THAN 2OO OHMS. THE PATIENT WOULD RETURN TO CLINIC FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL DX | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1388T/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |