BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERVENE LEAD

    MDR report key: 289893 · Received May 9, 2000

    Report

    Report Number
    2124215-2000-01612
    Event Type
    Malfunction
    Date Received
    May 9, 2000
    Date of Event
    January 26, 2000
    Report Date
    January 26, 2000
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A HIGH SHOCKING LEAD IMPEDANCE MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERVENE LEAD * LWS CARDIAC PACEMAKERS 497-23 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other THE DEVICE 101-/01077 WAS IMPLANTED 17-APR-1998| THE DEVICE 438-/09915R WAS IMPLANTED 17-APR-1998