FDA Adverse Event
Malfunction
Summary report: N
TENDRIL ST
MDR report key: 2013882
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01517
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- December 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
- WV
- 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 LEAD EXHIBITED AN IMPEDANCE INCREASE FROM 676 OHMS AT IMPLANT, TO 1001 OHMS IN (B)(6) 2010, TO 1447 OHMS ON (B)(6) 2010. 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 | 1788T/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |