BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOWNSIZE PLUS LEAD

    MDR report key: 94123 · Received March 6, 1997

    Report

    Report Number
    2124215-1997-00955
    Event Type
    Injury
    Date Received
    March 6, 1997
    Date of Event
    November 22, 1996
    Report Date
    December 18, 1996
    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 DOWNSIZE PLUS LEAD (0095-202392) WAS REMOVED FROM SERVICE FOUR DAYS AFTER INITIAL IMPLANT, DUE TO POOR R-WAVE. ANOTHER (0095) LEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOWNSIZE PLUS LEAD Implant TRANSVENOUS LEAD LWS CARDIAC PACEMAKERS 0095 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention THE DEVICE 0095/202365 WAS IMPLANTED 22-NOV-1996