FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 1073271
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02070
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- April 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
- AR
- 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 IMPEDANCE HAD INCREASED FROM 500 OHMS AT IMPLANT TO 1200 OHMS. SENSING THRESHOLDS DECREASED FROM GREATER THAN 3 MV TO 1.9 MV AND CAPTURE THRESHOLDS INCREASED FROM 1.0 V, 0.5 MS TO 4.0 V, 0.5 MS. NOISE WAS ALSO NOTED ON THE ATRIAL LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PROGRAMMED FROM DDD TO VVI MODE. THE PATIENT WAS AYSMPTOMATIC.
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 |