BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 3053281 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04917
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 6, 2013
    Report Date
    May 1, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THIS DEVICE HAS BEEN RETURNED TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A SEPARATED HEADER. ALTHOUGH EVIDENCE INDICATES EXTERNAL STRESS MAY HAVE BEEN A FACTOR IN THE HEADER BECOMING LOOSE, THE CAUSE OF THE ABNORMALITY WAS ISOLATED TO INSUFFICIENT BONDING BETWEEN THE MEDICAL ADHESIVE AND THE TITANIUM CASING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE EXPLANT PROCEDURE, VISUAL OBSERVATION REVEALED THIS DEVICE HEADER WAS SEPARATED FROM THE DEVICE BODY. THERE HAD BEEN NO ALLEGATIONS AGAINST THE DEVICE PERFORMANCE WHILE IMPLANTED. REPORTEDLY, SOME DIFFICULTY HAD BEEN ENCOUNTERED REMOVING THE LEADS FROM THE HEADER. IT WAS UNKNOWN WHAT EQUIPMENT WAS USED DURING THE PROCEDURE AND WHETHER FORCE WAS USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157005 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H190

    Patients

    Seq Age Sex Outcome Treatment
    1