BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT DR

    MDR report key: 3993289 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14654
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. CONCOMITANT MEDICAL PRODUCTS: 6947M-62 LEAD; IMPLANTED: (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED A PROBLEM WITH WIRELESS TELEMETRY AND IT WAS CONFIRMED THAT WIRELESS TELEMETRY WAS NO LONGER AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WIRELESS TELEMETRY NO LONGER WORKED IN THIS DEVICE. THE DEVICE WAS ABLE TO BE INTERROGATED WITH WIRED TELEMETRY. 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
    470318 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR 5076-52 LEAD