BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2954423 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02261
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    December 27, 2012
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015/S055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE SENSING INTEGRITY COUNT (SIC) ON THE RIGHT VENTRICULAR (RV) LEAD INDICATED OVERSENSING AND NON-SUSTAINED VENTRIC ULAR TACHYCARDIA EPISODES WHICH TRIGGERED A LEAD INTEGRITY ALERT (LIA). A CONNECTION ISSUE BETWEEN THE LEAD AND IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) IS SUSPECTED. THE PATIENT WILL CONTINUE TO BE MONITORED AND THE LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SENSING INTEGRITY COUNT (SIC) ON THE RIGHT VENTRICULAR (RV) LEAD INDICATED OVERSENSING AND NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES WHICH TRIGGERED A LEAD INTEGRITY ALERT (LIA). THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58055 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1