BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3993288 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09404
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    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. CONCOMITANT: 429688 LEAD, IMPLANTED 2014-(B)(6), 5076-52 LEAD, IMPLANTED 2014-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD SHOWED INTERMITTENT POST PACE T-WAVE OVERSENSING (TWOS). REPROGRAMMING WAS PERFORMED AND THE RV LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PHRENIC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE CAPTURE MANAGEMENT WAS PROGRAMMED OFF AND OUTPUT WAS LOWERED. THE LV 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
    469521 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention DTBA1D1 ICD