BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2050255 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03219
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 14, 2011
    Report Date
    March 16, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE MEMORY CONFIRMED THE DEVICE WAS OPERATING IN A HIGHER CURRENT BIN. BASED ON THE CHARGE TIME MEASUREMENTS IN THE MEMORY DOWNLOAD AND THE CALCULATED CURRENT BIN, THE DEVICE SHOULD HAVE APPROXIMATELY 20 TO 30 PERCENT REMAINING CAPACITY, WHICH IS CONSISTENT WITH THE BATTERY STATUS GAUGE AT THE MOST RECENT DEVICE CHECK. FURTHER REVIEW OF THE DEVICE MEMORY COULD NOT ASCERTAIN THE REASON WHY THE DEVICE DISPLAYED LESS THAN .5 YEARS DURING THE DEVICE CHECK ONE MONTH PRIOR TO THE LAST DEVICE CHECK.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PACEMAKER BATTERY LONGEVITY WAS FLUCTUATING FROM 1.5-2 YEARS TO LESS THAN .5 YEARS AND NOW SHOWING 2.5 YEARS REMAINING. THE PATIENT PACES 100 PERCENT AND THERE WERE NO PARAMETER CHANGES MADE.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR 4469| 4458| 1291| 1290