FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1073562
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02002
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 18, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS
- 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 DURING ROUTINE FOLLOW UP, INTERROGATION REVEALED ATRIAL UNDERSENSING IN BOTH UNIPOLAR AND BIPOLAR SENSING CONFIGURATIONS. LEAD IMPEDANCE WAS 432 OHMS BIPOLAR AND 302 OHMS UNIPOLAR. DURING AN ATRIAL CAPTURE TEST, THERE WAS NO CAPTURE UP TO 7.5 V. AN X-RAY WAS PERFORMED REVEALING DISLODGEMENT. THE LEAD WAS SUCCESSFULLY REPOSITIONED.
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/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |