BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2161257 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-07259
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 14, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT STATED THE DEVICE WAS IN ELECTIVE REPLACEMENT NEAR (ERN) STATUS AND STATED A TWO MONTH FOLLOW-UP PERIOD WAS OKAY. 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 DEVICE HAD A MAGNET RATE OF 90 PPM AND A LONGEVITY REMAINING ESTIMATE OF LESS THAN A (B)(6). IT WAS REPORTED THE GAS GAUGE WAS SHOWING ONE QUARTER BEFORE ELECTIVE REPLACEMENT TIME (ERT). THE HEALTH CARE PROVIDER ASKED WHETHER A PLANNED FOLLOW-UP APPOINTMENT IN TWO MONTHS WOULD BE APPROPRIATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)