FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 1955857
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00714
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- October 14, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- 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 VENTRICULAR LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE, HIGH IMPEDANCES OF 2190-2250 OHMS AND HIGH CAPTURE THRESHOLD OF 3 V AT 0.4 MS IN THE BIPOLAR CONFIGURATION. AS MEASURED VALUES IN THE UNIPOLAR CONFIGURATION WERE NORMAL, THE VENTRICULAR POLARITY WAS CHANGED TO UNIPOLAR. THE PATIENT 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/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |