BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3990091 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08814
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 MEDICAL PRODUCTS: 1056T ST. JUDE LEAD, IMPLANTED: (B)(6) 2009; 5076-52 LEAD, IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE GRADUALLY ROSE BUT ROSE FASTER IN THE PREVIOUS TWO MONTHS AND WAS HIGH. IT WAS NOTED THAT "FAST RISE MAY OR MAY NOT COINCIDE WITH A FALL THE PATIENT EXPERIENCED." THE THRESHOLDS WERE NOTED TO BE "OK." THREE DAYS LATER THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN. THE RV LEAD IMPEDANCE WAS STILL NOTED TO BE HIGH. 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
    463004 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR D314TRG ICD