BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2649622-2013-00612

    MDR report key: 2952564 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00612
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    September 22, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK AS A RESULT OF T-WAVE OVERSENSING (TWOS) WITH THE RIGHT VENTRICULAR (RV) LEAD DUE TO THE PATIENT'S HYPERKALEMIA THAT WERE SENSED AS VENTRICULAR FIBRILLATION (VF). THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56869 LWS MPRI 694765 TDG555859V

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Life Threatening (B)(4) IMPLANTABLE PACEMAKER CARDIO/DEFIB