BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVICE 0175/122949 IMPLANTED 12-AUG-2009

    MDR report key: 1540932 · Received November 10, 2009

    Report

    Report Number
    2124215-2009-24478
    Event Type
    Injury
    Date Received
    November 10, 2009
    Date of Event
    August 12, 2009
    Report Date
    October 12, 2018
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Removal / Correction Number
    Z-1144/114
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DURING A CHANGE OUT PROCEDURE THE PHYSICIAN ATTEMPTED TO REMOVE THIS RIGHT VENTRICULAR (RV) LEAD AGAIN WITHOUT SUCCESS. THE RV LEAD WAS RE-CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE 0175/122949 IMPLANTED 12-AUG-2009 IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R