BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2905542 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-13433
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 2, 2012
    Report Date
    October 17, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    - -

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE ANALYSIS, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS RETURNED TWO YEARS AFTER EXPLANT. ANALYSIS DETERMINE THIS DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS. TO DETERMINE IF THE BATTERY DEPLETED IN A NORMAL FASHION, OUR LABORATORY TECHNICIANS USED ENGINEERING FORMULAS TO CALCULATE EXPECTED LONGEVITY. BASED ON THE AVAILABLE PARAMETERS AND THERAPY HISTORY, WE DETERMINED THAT THIS DEVICE DID NOT MEET EXPECTED LONGEVITY. DESPITE EXHAUSTIVE ANALYSIS, THE CONDITION THAT LED TO THE PREMATURE BATTERY DEPLETION COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES AND NO REPORTED ADVERSE PATIENT EFFECTS. INITIAL ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY DETERMINED THIS PRODUCT DID NOT MEET LONGEVITY EXPECTATIONS. FURTHER ANALYSIS WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11374 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H190

    Patients

    Seq Age Sex Outcome Treatment
    1 H190| 0165| 4193| 4054