BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2011-07215

    MDR report key: 2162569 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07215
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 A PACEMAKER SHOWED 1.5 YEARS OF REMAINING LONGEVITY WITH A MAGNET RATE OF 100. HOWEVER, AT THE FOLLOWING SIX MONTH FOLLOW UP THE DEVICE WAS AT END OF LIFE (EOL). THERE WAS NO PROGRAM CHANGES MADE WITH THIS DEVICE. THERE WAS INQUIRY OF ANY ADVISORY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SPECIFIC MODEL/SERIALS OR ASSOCIATED PATIENT WERE NOT KNOWN. IN ADDITION, IT WAS NOT KNOWN IF THESE DEVICE HAD BEEN OR WOULD BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVZ GUIDANT PUERTO RICO BV BRADY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1