BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 3232013 · Received July 17, 2013

    Report

    Report Number
    2124215-2013-11346
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    KRG
    PMA / PMN Number
    P910077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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 DURING AN IN-CLINIC FOLLOW UP, THE PATIENT WAS SITTING IN A CHAIR WITH THE WAND FROM THIS PROGRAMMER OVER THE IMPLANTED PACEMAKER. WHILE PRINTING REPORTS FROM THE PROGRAMMER TO AN EXTERNAL PRINTER, PACING INHIBITION FOR GREATER THAN TWO SECONDS WAS OBSERVED. THE PATIENT IS PACEMAKER DEPENDENT AND HAD EXPERIENCED DIZZINESS. NO NOISE WAS OBSERVED, JUST PURE PACING INHIBITION. THE PROGRAMMER WAND CORD WAS REPORTED TO HAVE ABRADED INSULATION. SENSITIVITY PROGRAMMING CHANGES WERE MADE AND NO FURTHER PACING INHIBITION WAS OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332730 ZOOM KRG GUIDANT PUERTO RICO BV 3120

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 430-07| 432-03| 1298| 294-09| S606