BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERVENE LEAD

    MDR report key: 293819 · Received August 8, 2000

    Report

    Report Number
    2124215-2000-02138
    Event Type
    Malfunction
    Date Received
    August 8, 2000
    Date of Event
    August 3, 1999
    Report Date
    August 13, 1999
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THE PHYSICIAN ENCOUNTERED DIFFICULTY INTERROGATING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE SYSTEM APPEARED TO HAVE 'RESET'. IN ADDITION, AN X-RAY REVEALED A FRACTURE OF THE SHOCKING LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERVENE LEAD * LWS CARDIAC PACEMAKERS 497-19 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other THE DEVICE 101-/110585 WAS IMPLANTED 28-NOV-1997| THE DEVICE 432-/74203R WAS IMPLANTED 28-NOV-1997| THE DEVICE 0155/201290 WAS IMPLANTED 05-AUG-1999| THE DEVICE 1831/105892 WAS IMPLANTED 05-AUG-1999