BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3992769 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09670
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 CONTINUED: 5076-52 LEAD, IMPLANTED 2013-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY SHOWED THE RIGHT VENTRICULAR (RV) LEAD WITH INAPPROPRIATE PACING SPIKES. ELECTROGRAM SHOWED INCREASED PROGRAMMED INTERVALS WITH OCCASIONAL BLOCKED VENTRICULAR BEATS. 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
    470715 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR D314DRM ICD