FDA Adverse Event
Malfunction
Summary report: N
TENDRIL DX
MDR report key: 1073297
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02096
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- May 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
- MI
- 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 WENT FROM A CONSISTENT MEASUREMENT OF 300 TO 400 OHMS IMPEDANCE FROM IMPLANT TO LAST FOLLOW-UP IN NOVEMBER 2007 TO 1200 TO 1450 OHMS. THERE WERE LOWER IMPEDANCE MEASUREMENTS OF 356 OHMS WHEN SENSING UNIPOLAR RING TO CASE. THE LEAD WOULD BE REPLACED DURING AN UPCOMING PULSE GENERATOR CHANGE OUT.
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 | 1388TC/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |