BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 3961725 · Received July 28, 2014

    Report

    Report Number
    2124215-2014-14548
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    February 7, 2014
    Report Date
    May 21, 2014
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWP
    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 EXPLANT OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PHYSICIAN REPORTED EXPERIENCING DIFFICULTY WITH THE RIGHT VENTRICULAR (RV) SETSCREW. AFTER FURTHER DISCUSSION WITH BOSTON SCIENTIFIC TECHNICAL SERVICES, IT WAS DISCOVERED THAT BOTH THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) DISTAL SETSCREWS HAD NOT BEEN LOOSENED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439199 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR LWP GUIDANT PUERTO RICO BV H215

    Patients

    Seq Age Sex Outcome Treatment
    1