BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOCARDIAL SUTURELESS LEAD

    MDR report key: 186688 · Received August 5, 1998

    Report

    Report Number
    2124215-1998-01277
    Event Type
    Injury
    Date Received
    August 5, 1998
    Date of Event
    December 2, 1997
    Report Date
    December 2, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THESE TWO EPICARDIAL RATE SENSING LEADS (0030'S) WERE CAPPED AND ABANDONED DUE TO HIGH IMPEDANCE AND HIGH PACING THRESHOLD ON ONE LEAD. CPI DID NOT RECEIVE THE LEADS BACK FOR ANALYSIS, CPI COULD NOT DETERMINE WHICH LEAD WAS AT FAULT, THEREFORE WE ARE REPORTING ON SERIAL NUMBER 042949.

    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 55 YR Required Intervention THE DEVICE 0040/104779 WAS IMPLANTED 20-DEC-1988| THE DEVICE 1625/110533 WAS IMPLANTED 06-OCT-1995| THE DEVICE 0041/109391 WAS IMPLANTED 20-DEC-1988| THE DEVICE 0030/042948 WAS IMPLANTED 20-DEC-1988| THE DEVICE 0014/200481 WAS IMPLANTED 02-DEC-1997