FDA Adverse Event
Malfunction
Summary report: N
TENDRIL DX
MDR report key: 2013860
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01357
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- December 2, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- 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 2500 OHMS IMPEDANCE AND A POLARITY SWITCH OCCURRED. AS THERE WAS STILL GOOD SENSING IN UNIPOLAR, THE PROGRAMMED MODE WAS CHANGED TO VDD AND THE PATIENT WOULD BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL DX | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1388T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |