BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 2123802 · Received June 14, 2011

    Report

    Report Number
    2182208-2011-00715
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    July 22, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT INVOLVES A LEGAL CASE IN PROGRESS OR POTENTIAL LITIGATION. THE PROPRIETARY NATURE OF THE EVENT MAY AFFECT FOLLOW UP EFFORTS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO THE HOSPITAL FOR INAPPROPRIATE THERAPY FROM THEIR DEVICE DUE TO AN APPARENT "MALFUNCTION". THE PATIENT CONTINUED TO RECEIVE INAPPROPRIATE THERAPY UNTIL THE DEVICE BATTERY WAS EXHAUSTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC, INC. ICD/MEDT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 6949 IMPLANTABLE TACHY LEAD