BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 1050586 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01553
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    March 1, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 THE LEAD EXHIBITED 130 TO 140 OHMS IMPEDANCE. THE P-WAVES WERE AT 0.3 MV. LOSS OF CAPTURE WAS AT 7.5 V, 0.5 MS. THE PULSE GENERATOR WAS SET TO DDD AT 50 PPM AND THE PACE PERCENTAGE WAS LESS THAN ONE PERCENT FOR BOTH CHANNELS. THE PULSE GENERATOR WAS REPROGRAMMED TO VVI AT 50 PPM. THE PATIENT WOULD BE MONITORED AT REGULAR FOLLOW-UPS.

    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/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1