BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOCARDIAL SUTURELESS LEAD

    MDR report key: 186822 · Received August 5, 1998

    Report

    Report Number
    2124215-1998-01139
    Event Type
    Malfunction
    Date Received
    August 5, 1998
    Date of Event
    May 20, 1998
    Report Date
    May 20, 1998
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THESE TWO MYOCARDIAL LEADS WERE REMOVED FROM SERVICE DUE TO FRACTURE. THEY WERE REPLACED WITH A NEW SENSING LEAD MODEL 12/200894.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYOCARDIAL SUTURELESS LEAD Implant MYOCARDIAL LEAD LWS CARDIAC PACEMAKERS 0030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other THE DEVICE 0012/200894 WAS IMPLANTED 20-MAY-1998| THE DEVICE 0041/101885 WAS IMPLANTED 02-SEP-1987| THE DEVICE 0041/101909 WAS IMPLANTED 02-SEP-1987| THE DEVICE 0030/072188 WAS IMPLANTED 02-SEP-1987| THE DEVICE 1746/605889 WAS IMPLANTED 22-DEC-1997