BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2173338 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-12227
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    January 1, 2007
    Report Date
    June 13, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, INTERROGATION REVEALED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI), END OF LIFE (EOL) AND STORAGE MODE. THE RESULTS OF A LONGEVITY CALCULATION INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE AND PROGRAMMED SETTINGS. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, TWO CONSECUTIVE CHARGE TIMES IN EXCESS OF THE 18 SPECIFICATION TRIGGERED ERI EARLIER THAN EXPECTED. DEVICE CIRCUITRY WAS DESIGNED SUCH THAT THE ERI CHARGE TIME LIMIT OF 18 SECONDS WOULD BE REACHED NEAR THE CORRESPONDING ERI MONITORING VOLTAGE LIMIT. ENGINEERS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE A COMPONENT FAILURE OR PREMATURE BATTERY DEPLETION. RATHER, THE REPLACEMENT INDICATOR WAS DECLARED DUE TO A BUILD-UP OF INTERNAL BATTERY IMPEDANCE, PREVENTING THE DEVICE FROM MEETING ITS EXPECTED LONGEVITY PER DEVICE LABELING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DECLARED END OF LIFE (EOL) AND REMAINED IN THAT STATUS FOR APPROXIMATELY FOUR YEARS. THE DEVICE WAS CURRENTLY IN STORAGE MODE, WITH A BATTERY VOLTAGE OF 1.76 VOLTS. THE PATIENT IMPLANTED WITH THIS DEVICE WAS IN A STATE OF PARTIAL DO NOT RESUSCITATE (DNR) AND EXPERIENCED A SYNCOPAL EPISODE. THE PHYSICIAN ELECTED TO EXPLANT THIS DEVICE AND REPLACE WITH A BI-VENTRICULAR PACEMAKER. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H135

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R 4513| 1821| H135| 0125| 4269