FDA Adverse Event
Malfunction
Summary report: N
TENDRIL DX
MDR report key: 1955795
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00684
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- November 29, 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
- IL
- 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 RIGHT ATRIAL LEAD EXHIBITED LOW IMPEDANCE OF 190 OHMS AND OVERSENSING, CAUSING MODE SWITCH EVENTS TO OCCUR. THE OVERSENSING COULD BE REPRODUCED IN CLINIC WITH ISOMETRIC EXERCISES. IT WAS SUSPECTED THAT THE OVERSENSING MAY BE DUE TO MYOPOTENTIALS SINCE BOTH OF THE PATIENT'S LEADS WERE UNIPOLAR LEADS.
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 | 1388K/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | (B)(4) |