BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY II

    MDR report key: 2052650 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04230
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE EXPLANTED PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR ANALYSIS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE EXPLANT PROCEDURE, THE DEVICE SETSCREWS WERE STUCK. THE ATRIAL SETSCREW WAS ABLE TO BE LOOSENED HOWEVER THE VENTRICULAR SETSCREW REMAINED STUCK. THE VENTRICULAR LEAD WAS CUT AND ABANDONED SURGICALLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY II IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1283

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR S403| 4136| 4063| 1283| 4034