FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1050531
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01282
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- February 6, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 SINCE BEGINNING OF 2008, THE AUTOCAPTURE THRESHOLD RECORD SHOWED HIGH CAPTURE THRESHOLDS AND THE PATIENT FELT TWITCHING. CLINICAL TESTS SHOWED A THRESHOLD OF 0.652 V IN UNIPOLAR AND 1 V IN BIPOLAR. BIPOLAR SENSING WAS 2 MV. X-RAY DID NOT REVEAL ANY LEAD ANOMALIES. OVER-SENSING WAS NOT REPRODUCED WITH ISOMETRICS. THE PATIENT HAD COMPLETE HEART BLOCK AND WAS PACED 99 PERCENT OF THE TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1488TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |