BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2011-07429

    MDR report key: 2162541 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07429
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR LEAD WERE EXPLANTED DUE TO A PATIENT INFECTION. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. A REQUEST WAS MADE FOR PRODUCT RETURN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 0148| E110| T165| (B)(4)