BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE PATCH LEAD L67

    MDR report key: 108809 · Received July 8, 1997

    Report

    Report Number
    2124215-1997-01690
    Event Type
    Injury
    Date Received
    July 8, 1997
    Date of Event
    April 2, 1997
    Report Date
    April 2, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS LARGE PATCH LEAD WAS REMOVED FROM SERVICE, CAPPED. DURING A ROUTINE REPLACEMENT PROCEDURE OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE PHYSICIAN FOUND THE LEAD WAS FRACTURE, HE ELECTED TO REPLACE THE ENTIRE LEAD SYSTEM WITH AN ENDOTAK LEAD. TWO LARGE PATCH LEADS ARE INVOLVED IN THE PATIENT'S LEAD SYSTEM, CPI IS UNABLE TO DETERMINE WHICH SERIAL HAD THE PROBLEM, THEREFORE WILL REPORT ON SERIAL 120424 AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE PATCH LEAD L67 Implant LARGE PATCH LEAD LWS CARDIAC PACEMAKERS 0041 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention THE DEVICE 4312/030158 WAS IMPLANTED 11-APR-1990| THE DEVICE 0125/214263 WAS IMPLANTED 02-APR-1997| THE DEVICE 1600/756611 WAS IMPLANTED 22-DEC-1993| THE DEVICE 1763/802615 WAS IMPLANTED 02-APR-1997| THE DEVICE 4312/032049 WAS IMPLANTED 11-APR-1990| THE DEVICE 0041/120425 WAS IMPLANTED 11-APR-1990