BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENOUS

    MDR report key: 2161266 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-07647
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    PMA / PMN Number
    K893957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE PULSE GENERATOR (PG) CHANGEOUT PROCEDURE, BOTH RIGHT VENTRICULAR (RV) SET SCREWS WERE FROZEN. THE SET SCREWS WERE NOT ABLE TO BE LOOSENED. THE PHYSICIAN DECIDED TO CUT AND CAP THE RV LEAD AS IT WAS UNABLE TO BE REMOVED FROM THE HEADER OF THE DEVICE. THE DEVICE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENOUS IMPLANTABLE LEAD NVN GUIDANT PUERTO RICO BV 4261

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR 4457| S601| 4261| 4444| 1230| 1276