BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 3993242 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02331
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 25, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS AS A RESULT OF INTERMITTENT T-WAVE OVERSENSING (TWOS) ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE DID NOT APPLY TWOS DISCRIMINATOR. THIS OCCURRENCE WAS THE ONLY EPISODE AND THERE WAS NO OVERSENSING IN REAL TIME. THE DEVICE 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
    470228 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6932-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Life Threatening DVBC3D1 ICD