BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3861285 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07326
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 8, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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: D314TRM ICD, IMPLANTED (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PATIENT WAS "KICKED LIKE A MULE AND THEN THERE WAS NOTHING" AND THE PATIENT ALSO NOTED HEARING AN ALERT. FOLLOW-UP WITH THE DEVICE CLINIC NOTED THAT THE PATIENT IS NO LONGER FOLLOWED BY THAT CLINIC AND NO FURTHER INFORMATION COULD BE OBTAINED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339439 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Life Threatening 4196-88 LEAD