BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3905184 · Received July 1, 2014

    Report

    Report Number
    2649622-2014-07613
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED THAT THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A VENTRICULAR FIBRILLATION (VF) EPISODE. HIGH VOLTAGE THERAPY WAS PROVIDED MULTIPLE TIMES BUT WAS UNABLE TO BREAK THE RHYTHM. THE VF RHYTHM CONVERTED SPONTANEOUSLY. THE PATIENT IS NOTED TO HAVE LOST CONSCIOUSNESS, FELL AND CHIPPED TEETH DURING EPISODE. THE DEVICE AND LEAD REMAIN IN USE. THE LEAD WILL BE REPOSITIONED AND DEFIBRILLATION THRESHOLD TESTING WILL BE COMPLETED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382480 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR Hospitalization| R D314VRG ICD