BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 3043200 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01401
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 17, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE EXPLANT OF THIS DEVICE, THE PHYSICIAN THOUGHT THERE WERE ONLY 4 SETSCREWS TO LOOSEN, WHEN IN FACT THERE ARE 8. ONCE BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) EXPLAINED THAT, THEY LOOSENED ALL 8 AND REMOVED THE DEVICE WITHOUT ISSUE. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146968 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT PUERTO RICO BV H217

    Patients

    Seq Age Sex Outcome Treatment
    1