BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK TR

    MDR report key: 3043582 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02210
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NKE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. TO DATE, THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP VISIT, THIS PACEMAKER WAS FOUND TO HAVE A MAGNET RATE OF 100 BEATS PER MINUTE (BPM) AND THE BATTERY WAS SLIGHTLY ABOVE ELECTIVE REPLACEMENT INDICATOR (ERI). A REPLACEMENT PROCEDURE WAS SCHEDULED. BEFORE THE REPLACEMENT, IT WAS NOTED THAT THE DEVICE WAS AT END OF LIFE (EOL) AND THE DEVICE WAS UNABLE TO BE INTERROGATED. PREMATURE BATTERY DEPLETION (PBD) WAS SUSPECTED. DURING THE REPLACEMENT PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD WAS DISCONNECTED FROM THE SETSCREW AND IT WAS NOTED THAT THE PATIENT FAILED TO PACE. THE LEAD WAS THEN ATTACHED TO AN EXTERNAL PACING SYSTEM AND THE PATIENT SAFELY MAINTAINED TO A NORMAL SINUS RHYTHM AND THE PROCEDURE WAS COMPLETED. THE DEVICE WAS RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145090 CONTAK TR IMPLANTABLE PULSE GENERATOR NKE GUIDANT CRM CLONMEL IRELAND 1241

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R