BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1950449 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22524
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 16, 2010
    Report Date
    May 2, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT DISCUSSED THAT THE MAGNET RATE INDICATES ONE YEAR LONGEVITY REMAINING AND TO FOLLOW THIS AS THE INDICATOR. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS PATIENT LATER UNDERWENT A REPLACEMENT PROCEDURE AND THIS PRODUCT WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CALLER WAS INQUIRING ABOUT THE ESTIMATED REMAINING LONGEVITY FOR THIS PACEMAKER AS IN (B)(6) 2010 IT STATED TWO YEARS REMAINING AND IS NOW STATING LESS THEN .5 YEARS. HOWEVER, THE MAGNET RATE IS 100PPM. THERE HAVE BEEN NO CHANGES TO THE DEVICE OUTPUT AND PACING PERCENTAGE. IMPEDANCE MEASUREMENTS ARE SLIGHTLY HIGHER. HAS NOT INCREASED. NO OUTPUT CHANGES, IMPEDANCES ARE SLIGHTLY HIGHER.

    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 70 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)| (B)(4)