BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 3212433 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08809
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 29, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 IMPLANT OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) A FIELD REPRESENTATIVE REPORTED THAT THEY WERE HAVING DIFFICULTY REMOVING THE SET SCREW. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED THAT THERE WERE TWO SET SCREWS FOR THE PACE/SENSE PORTION OF THE LEAD. THE REPRESENTATIVE REPORTED THAT ONCE ALL SET SCREWS WERE LOOSENED, THE LEAD CAME OUT WITHOUT FURTHER COMPLICATION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THERE WAS NO IDENTIFYING PATIENT INFORMATION GIVEN AND A NAME FOR THE FIELD REPRESENTATIVE WAS NOT GIVEN TO TECHNICAL SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312723 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT PUERTO RICO BV H217

    Patients

    Seq Age Sex Outcome Treatment
    1