BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURELESS MYOCARDIAL LEAD

    MDR report key: 256029 · Received August 10, 1999

    Report

    Report Number
    2124215-1999-00644
    Event Type
    Malfunction
    Date Received
    August 10, 1999
    Date of Event
    April 30, 1999
    Report Date
    April 30, 1999
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS TRANSVENOUS DEFIBRILLATION LEAD,MODEL 4312 SN 043403 WAS FRACTURED. THIS WAS FOUND DURING A ROUTINE DEVICE REPLACEMENT WHEN TESTING OF THE LEAD WITH THE NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INDICATED AN ABNORMAL LEAD IMPEDANCE MEASUREMENT. THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURELESS MYOCARDIAL LEAD Implant LEAD LWS CARDIAC PACEMAKERS 4312 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other THE DEVICE 0144/304126 WAS IMPLANTED 30-APR-1999| THE DEVICE 0020/101254 WAS IMPLANTED 07-AUG-1992| THE DEVICE 0041/134434 WAS IMPLANTED 06-MAY-1991| THE DEVICE 1793/300397 WAS IMPLANTED 30-APR-1999| THE DEVICE 0041/134433 WAS IMPLANTED 06-MAY-1991| THE DEVICE 1746/608223 WAS IMPLANTED 30-APR-1999| THE DEVICE 4312/045289 WAS IMPLANTED 06-MAY-1991| THE DEVICE 1705/666933 WAS IMPLANTED 04-JAN-1995