BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2913231 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00591
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    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 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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) IMPEDANCES OF GREATER THAN 2300 OHMS. THE IMPEDANCES CAUSED A LEAD SAFETY SWITCH (LSS) AND IT LOOKS AS IF THEY HAVE BEEN RISING FOR GREATER THAN A YEAR. THERE WAS ALSO LOSS OF CAPTURE (LOC) AS WELL AS LEAD FRACTURE, OR SETSCREW ISSUES. THE PATIENT HAD NOT BEEN SEEN FOR A VERY LONG TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20691 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 4087| 4088| 1297