BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRON

    MDR report key: 290036 · Received May 9, 2000

    Report

    Report Number
    2124215-2000-01782
    Event Type
    Malfunction
    Date Received
    May 9, 2000
    Date of Event
    March 16, 2000
    Report Date
    March 16, 2000
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT WHILE THE PATIENT WAS IN FOR A ROUTINE FOLLOW-UP APPOINTMENT, AN ERROR CODE WAS NOTED. IT WAS ALSO REPORTED THAT THE PATIENT'S POCKET WAS BEING STIMULATED WITH PACING CAUSING PAIN, WHICH COULD BE REPRODUCED AT VARIOUS OUTPUTS. AN ATTEMPT WAS MADE TO REPROGRAM THE ICD TO OVO MODE, BUT THE REPROGRAMMING WOULD NOT TAKE EFFECT AND THE ICD DID NOT STOP PACING. AFTERWARD THE ICD UNDERWENT A RESET. THE SECOND ATTEMPT AT REPROGRAMMING WAS SUCCESSFUL AND THE ICD PACING STOPPED. REVIEW OF THE INFORMATION STORED IN THE ICD NOTED A DROP IN PACING IMPEDANCE MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRON IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS 101-05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other THE DEVICE 0144/332834 WAS IMPLANTED 21-MAR-2000| THE DEVICE 1851/302982 WAS IMPLANTED 21-MAR-2000| THE DEVICE 0040/104260 WAS IMPLANTED 17-JAN-1989| THE DEVICE 0040/103676 WAS IMPLANTED 17-JAN-1989