FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1050422
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01403
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 13, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH
- 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 VENTRICULAR LEAD EXHIBITED A BI- POLAR IMPEDANCE OF 1545 OHMS AND A UNIPOLAR IMPEDANCE OF 266 OHMS. IN 2007, BIPOLAR LEAD IMPEDANCE WAS 366 OHMS. BIPOLAR CAPTURE THRESHOLDS WERE 3.75 V, 1.0 MS AND UNIPOLAR CAPTURE THRESHOLDS WERE 0.75 V, 1.0 MS. THE PATIENT WAS AYSMPTOMATIC.
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 | 1688T/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |