BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3863256 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06613
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY HEARD AN AUDIBLE ALARM WHILE ON VACATION. THE PATIENT SAID THEY WERE "FEELING OK". THE PATIENT INDICATED THEY WERE "FRUSTRATED WITH OUTCOME OF CONVERSATION" AND REQUESTED TO SPEAK WITH A COMPANY SUPERVISOR. THE PATIENT WAS REFERRED TO THE CARDIOLOGIST. FOLLOW-UP WITH THE NURSE PRACTITIONER REVEALED THAT THERE WAS NOT A REMOTE TRANSMISSION SENT TO THE CLINIC, AND THE PATIENT HAD NOT SEEN THE PHYSICIAN. HOWEVER, THE PATIENT IS SCHEDULED FOR A FUTURE FOLLOW-UP VISIT. 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
    341294 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR (B)(4) ICD