BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2011-09740

    MDR report key: 2170944 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09740
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INFORMATION KNOWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE REPLACEMENT PROCEDURE, DIFFICULTY WAS ENCOUNTERED REMOVING THE LEADS FROM THIS DEVICE HEADER. THIS DEVICE WAS SUCCESSFULLY REPLACED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IT IS UNKNOWN WHETHER THE LEADS ARE BOSTON SCIENTIFIC PRODUCTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LWS GUIDANT PUERTO RICO BV TACHY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1