BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3782018 · Received April 30, 2014

    Report

    Report Number
    2649622-2014-04805
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 2, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CONCOMITANT PRODUCTS: PRODUCT ID 4968-25, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO FAINTING EPISODES WHILE PLAYING. IT WAS ALSO NOTED THAT THERE HAS BEEN A DEVICE ALARM HEARD DUE TO OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. INTERROGATION OF THE DEVICE REVEALED FAST VENTRICULAR TACHYCARDIA EPISODES WHICH WERE TERMINATED WITH SHOCK THERAPY. NON SUSTAINED VENTRICULAR TACHYCARDIA WAS NOTED. LOW R WAVES WERE ALSO NOTED. TWO WEEKS LATER THE DEVICE WAS CHECKED AND NO EPISODES WERE NOTED. 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
    260147 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693552

    Patients

    Seq Age Sex Outcome Treatment
    1 00002 YR Hospitalization (B)(4)