FDA Adverse Event
Malfunction
Summary report: N
TENDRIL ST
MDR report key: 1896450
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05160
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- August 27, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 LOSS OF CAPTURE, AN OUT OF RANGE IMPEDANCE MEASUREMENT AND 1.3 MV - 1.6 MV SENSING IN THE BIPOLAR CONFIGURATION. X-RAY SHOWED NO ANOMALIES. THE LEAD WOULD BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1888TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |