FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 1223875
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03204
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- August 7, 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
- CA
- 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 NOISE. THE NOISE COULD NOT BE REPRODUCED WITH ISOMETRICS. IT WAS NOTED THAT THE LEAD IMPEDANCE HAD BEEN RISING GRADUALLY AND WAS 927 OHMS AT THE LAST INTERROGATION. THE NON-PACEMAKER DEPENDENT PATIENT WAS SCHEDULED FOR A FOLLOW-UP, AND 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 | 1688TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |