BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX VR

    MDR report key: 1855018 · Received October 5, 2010

    Report

    Report Number
    6000094-2010-01770
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 12, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S40
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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. THE DEVICE MODEL NUMBER 6949 IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTERROGATION JUST PRIOR TO A SCHEDULED DEVICE REPLACEMENT A PATIENT EXPERIENCED A VENTRICULAR FIBRILLATION EPISODE AND RECEIVED 6 SHOCKS. THE SHOCKS DELIVERED WERE 0.3 JOULES INSTEAD OF 30 JOULES. THE SHOCKS DID NOT STOP THE FIBRILLATION, BUT IT RESOLVED SPONTANEOUSLY. THE SHOCK IMPEDANCE WAS HIGH AND AFTER THE EPISODE THE DEVICE HAD AN ELECTRICAL RESET. THE DEVICE AND THE DEFIBRILLATION LEAD WERE REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7290CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention