BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 4834214 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06761
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 29, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYSIS OF THE DEVICE MEMORY INDICATED RV (RIGHT VENTRICULAR) OVERSENSING AND UNEXPECTED DELIVERY OF A VENTRICULAR TACHYARRYTHMIA THERAPY. IT WAS NOTED T-WAVE OVERSENSING (TWOS) WAS IDENTIFIED IN VENTRICULAR TACHYCARDIA (VT) NON-SUSTAINED (NS) EPISODES, ALONG WITH A VENTRICULAR FIBRILLATION (VF) EPISODE #15 LEADING TO INAPPROPRIATE SHOCK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. IT WAS FURTHER NOTED A HIGH NUMBER OF NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES WERE OBSERVED WITH RIGHT VENTRICULAR (RV) LEAD T-WAVE OVERSENSING. 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
    379929 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944A75

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Life Threatening