BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 1073360 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02149
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    April 14, 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 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 A FOLLOW UP AFTER LEAD POSITIONING, THE VENTRICULAR SENSING AMPLITUDE DROPPED FROM 8.9 MV TO 4.2-5.3 MV AND CAPTURE THRESHOLD INCREASED FROM 0.5 V TO 2.5 V. ACUTE LEAD DISLODGEMENT WAS SUSPECTED. THE LEAD DISLODGED ONCE A MONTH PRIOR, AND THE PATIENT REFUSED TO UNDERGO ANOTHER REPOSITIONING PROCEDURE. THE DEVICE WAS REPROGRAMMED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1