BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE PATCH LEAD L67

    MDR report key: 143273 · Received November 7, 1997

    Report

    Report Number
    2124215-1997-02960
    Event Type
    Injury
    Date Received
    November 7, 1997
    Date of Event
    September 12, 1997
    Report Date
    September 12, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS LARGE PATCH LEAD WAS CAPPED DUE TO AN IMPEDANCE ISSUE. THE LEAD WAS REPLACED WITH AN ENDOTAK LEAD. TWO PATCH LEADS ARE INVOLVED IN THE PATIENT'S LEAD SYSTEM (MODEL 0041 SERIAL 760110 AND MODEL 0040 SERIAL 100147). CPI IS UNABLE TO DETERMINE WHICH LEAD HAS THE PROBLEM, THEREFORE WILL REPORT ON LEAD 0041/760110 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 81 YR Required Intervention THE DEVICE 1746/600643 WAS IMPLANTED 30-MAY-1996| THE DEVICE 0072/005555 WAS IMPLANTED 12-SEP-1997| THE DEVICE 4261/232035 WAS IMPLANTED 29-NOV-1995| THE DEVICE 0446/707379 WAS IMPLANTED 29-NOV-1995| THE DEVICE 0030/018965 WAS IMPLANTED 11-JUN-1987| THE DEVICE 0030/018966 WAS IMPLANTED 11-JUN-1987| THE DEVICE 0040/100147 WAS IMPLANTED 11-JUN-1987