BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3864715 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07557
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 MEDICAL PRODUCTS: D154ATG ICD, IMPLANTED: (B)(6) 2006. A 5076-52 LEAD, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE. DURING A ROUTINE CHANGEOUT PROCEDURE, THE SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE WAS RECORDED AS "NONE" ON THE NEW DEVICE. FURTHER TESTING THROUGH THE DEVICE AND THE ANALYZER CONFIRMED AN SVC COIL FRACTURE. THE SVC PORTION OF THE LEAD WAS PROGRAMMED OFF AND 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
    338293 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694465

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention 407658 LEAD