BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1042524 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34115
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 5, 2008
    Report Date
    April 4, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0016-11 TO Z-0017-11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A SAVE TO DISK AND MEMORY DUMP WAS SENT TO BOSTON SCIENTIFIC. ANALYSIS OF THIS DATA CONFIRMED THAT THE DEVICE MAGNETIC SWITCH WAS CLOSED IN THE THREE MEMORY DUMPS. MAGNET USE WAS DISABLED AND TACHY THERAPY WAS AVAILABLE. THE DEVICE WAS AT BEGINNING OF LIFE WITH A MONITORING VOLTAGE OF 3.1 V. THE SWITCH IN THE CLOSED POSITION WILL ADD APPROXIMATELY 33% TO THE OPERATING CURRENT OF THE DEVICE. THIS WILL REDUCE THE LONGEVITY APPROXIMATELY 25%. THE EXPECTED LONGEVITY OF THIS DEVICE IS APPROXIMATELY THREE YEARS. IT WAS LATER REPORTED THAT DAILY MEASUREMENTS WERE NOT UPLOADING TO LATITUDE AND THE DEVICE HAD NOT PERFORMED AUTO CAPACITOR REFORMS. TS HAD THE REPRESENTATIVE TOGGLE THE PATIENT TRIGGERED MONITOR FEATURE TO REACTIVATE DAILY MEASUREMENTS AND CAPACITOR REFORMS. CHARGE TIME WAS 6.4 SECONDS AND BATTERY VOLTAGE WAS 3.18 V. THE DEVICE WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (B)(4) RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS BEEPING AND THE REED SWITCH WAS STUCK. A MAGNET WAS USED TO DISABLE THERAPY DURING SURGERY. A BOSTON SCIENTIFIC (B)(4) TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED ENABLING MAGNET USE TO OFF WHICH STOPPED THE BEEPING AND PREVENTED TACHY THERAPY FROM BEING DISABLED. TACHY MODE WAS PROGRAMMED TO MONITOR PLUS THERAPY. TS DISCUSSED THAT SINCE THE DEVICE'S REED SWITCH IS STUCK CLOSED THE DEVICE WILL CONTINUE TO THINK A MAGNET IS PRESENT. A BOSTON SCIENTIFIC REPRESENTATIVE WILL DO A SAVE TO DISK AND MEMORY DUMP AND SEND THIS DATA INTO TS. ENGINEERING WILL ANALYZE THIS DATA AND POSSIBLY IDENTIFY THE FAILURE MECHANISM AND LONGEVITY IMPACT. THE REPRESENTATIVE WONDERED IF HE WILL GET ALERTS FROM LATITUDE. A BOSTON SCIENTIFIC EMPLOYEE DISCUSSED THAT LATITUDE WILL NOT BE AFFECTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS DURING THE PROCEDURE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| O| R THE DEVICE 4555/157550 WAS IMPLANTED 03-MAY-2007| THE DEVICE (B)(4)| THE DEVICE (B)(4)| THE DEVICE (B)(4)| THE DEVICE 4470/536561 WAS IMPLANTED 03-MAY-2007| THE DEVICE (B)(4) WAS USED DURING THE EVENT.| THE DEVICE 6482 024187 WAS USED DURING THE EVENT.| THE DEVICE 0185/139528 WAS IMPLANTED 03-MAY-2007