FDA Adverse Event
Malfunction
Summary report: N
TENDRIL DX
MDR report key: 1050525
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01501
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- March 1, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- WI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE EGM'S. ARM EXERCISES REPRODUCED INHIBITION AND NOISE ON THE SURFACE ECG'S. HIGH CAPTURE THRESHOLDS WERE NOTED IN THE BIPOLAR CONFIGURATION. LEAD IMPEDANCES WERE NORMAL TO HIGH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL DX | PERMANENT PACEMAKER ELECTRODE | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1388TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |