BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3992901 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09609
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT "THE DEVICE WENT ON NEAR THIRTY ONE TIMES AND DAMN NEAR KILLED ME". THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NOW, THE PATIENT IS HEARING A SOUND FROM THE DEVICE "LIKE A BRITISH SCION". FOLLOW UP INDICATED THAT THE SUPERIOR VENA CAVA (SVC) COIL OF THE RIGHT VENTRICULAR LEAD HAD A SLIGHT RISE IN IMPEDANCE. 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
    466770 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR D154VWC ICD