FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 1222969
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03248
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- August 14, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED GREATER THAN 2000 OHMS IMPEDANCE. NO NOISE WAS OBSERVED. AT THE LAST CHECK IN 2008, IMPEDANCE WAS MEASURED AT 420 OHMS. P WAVES WERE MEASURED TO BE GREATER THAN 3.0 MV, AND THE ATRIAL PACING THRESHOLD WAS CONSISTENT WITH THE LAST CHECK AT 0.5 V.
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 |