BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3991719 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-07973
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 8, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 PRODUCT: 680R26 HEART RING, IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER (EMERGENCY ROOM) WITH COMPLAINTS OF THEIR DEVICE ALARMING OVER THE PAST TWENTY-FOUR HOURS. AN INTERROGATION WAS DONE AND REVEALED THAT THERE WAS HIGH SVC (SUPERIOR VENA CAVA) IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. POSSIBLE LEAD FRACTURE WAS SUSPECTED. THE SVC COIL OF THE RV LEAD WAS PROGRAMMED OFF. 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
    471982 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention D314VRM ICD