FDA Adverse Event
Malfunction
Summary report: N
ACTIVE FIXATION ENDOCARDIAL LEAD
MDR report key: 1073272
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02071
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- April 1, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED - COMPANY REPRESENTATIVE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED 1500 TO 1900 OHMS IMPEDANCE IN BOTH CONFIGURATIONS. THE PATIENT WAS PACEMAKER DEPENDENT WITH COMPLETE HEART BLOCK AND PACING IN VVI MODE. HIGH THRESHOLDS WERE OBSERVED IN THE PAST FOUR YEARS AND ADEQUATE CAPTURE AND SENSING WERE PRESENT. THE PATIENT HAD AN UNDERLYING RHYTHM IN THE 30'S. THE LEAD ISSUE WOULD BE ADDRESSED ONLY IF PACING IS AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVE FIXATION ENDOCARDIAL LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1188T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |