BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 4158226 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-10603
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    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 PRODUCTS: 4194-78 LEAD, IMPLANTED: (B)(6) 2008; ICF09B-52 LEAD, IMPLANTED: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) COIL OF THE RIGHT VENTRICULAR LEAD WAS POSSIBLY FRACTURED AND HAD HIGH IMPEDANCE. THE SCV COIL PORTION OF THE LEAD WAS PROGRAMMED OFF AND THE LEAD REMAINS IN USE AND WILL BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637382 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention D284TRK ICD