BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3508520 · Received December 9, 2013

    Report

    Report Number
    3004209178-2013-22623
    Event Type
    Malfunction
    Date Received
    December 9, 2013
    Report Date
    September 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. CONCOMITANT MEDICAL PRODUCTS: A 4296-78 IMPLANTABLE PACING LEAD: (B)(6) 2013. A 5076-45 IMPLANTABLE PACING LEAD: (B)(6) 2013. A 6935M55 IMPLANTABLE TACHY LEAD: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATED THEY HAD THEIR DEVICE CHECKED AND ADJUSTED AND ONE DAY AFTER IT WAS REGULATED THE PATIENT STARTED TO FEEL SOME HICCUPS, SOME BIG ONES AND LITTLE ONES. FOLLOW UP WITH THE PHYSICIAN WAS CONDUCTED BUT THEY WERE NOT ABLE TO PROVIDE ANY ADDITIONAL INFORMATION. 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
    639359 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention