BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT VR

    MDR report key: 3992713 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14772
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THAT MONITOR SVT (SUPRAVENTRICULAR TACHYCARDIA) EPISODES WERE NOT SHOWN IN THE QUICKLOOK SCREEN, WHICH THE CLINICIAN FOUND CONFUSING AND MISREPRESENTATIVE OF THE PATIENT'S CONDITION. THE DEVICE 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
    469519 PROTECTA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR 694765 LEAD