BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBCUTANEOUS PATCH

    MDR report key: 169342 · Received May 5, 1998

    Report

    Report Number
    2124215-1998-00908
    Event Type
    Malfunction
    Date Received
    May 5, 1998
    Date of Event
    February 23, 1998
    Report Date
    March 17, 1998
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS ENDOTAK (0064/004809) TRANSVENOUS DEFIBRILLATION LEAD WAS REMOVED FROM SERVICE DUE TO A RATE SENSING ISSUE. THE PATIENT WAS ADMITTED FOR ROUTINE REPLACEMENT OF AN IMPLANTABLE CARDIOVERTOR DEFIBRILLATOR (ICD), DURING TESTING WITH THE NEW ICD A MESSAGE OF SHORTED LEAD APPEARED. THE ICD WAS REMOVED AND THE ENDOTAK LEADS WERE CAPPED. THE NEXT DAY (02/24/98) THE PHYSICIAN ATTEMPTED TO REMOVE THE ENDOTAK LEADS BUT WAS UNSUCCESSFUL. ON 02/25/98 A STERNOTOMY WAS PERFORMED AND THE ENDOTAK LEADS WERE EXPLANTED. THE ENDOTAK LEAD (0063/001956) WAS ALSO REMOVED AND IS BEING REPORTED DUE TO LABORATORY RESULTS, NO ALLEGATION WAS MADE AGAINST THIS LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBCUTANEOUS PATCH Implant SUBCUTANEOUS LEAD LWS CARDIAC PACEMAKERS 0063 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other THE DEVICE 4312/048670 WAS IMPLANTED 07-SEP-1994| THE DEVICE 1746/603758 WAS IMPLANTED 23-FEB-1998| THE DEVICE 0041/226124 WAS IMPLANTED 25-FEB-1998| THE DEVICE 1746/603764 WAS IMPLANTED 25-FEB-1998| THE DEVICE 0041/226151 WAS IMPLANTED 25-FEB-1998| THE DEVICE 0064/004809 WAS IMPLANTED 07-JAN-1994| THE DEVICE 4312/054884 WAS IMPLANTED 07-SEP-1994| THE DEVICE 1600/758260 WAS IMPLANTED 07-SEP-1994