BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 4160559 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19106
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 PRODUCTS 6935-65 LEAD, IMPLANTED: (B)(6) 2013; 4194-88 LEAD, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT¿S DAUGHTER REPORTED THAT THE PATIENT STATED THAT THEY HAD BEEN HEARING TONES FROM THE DEVICE THAT SOUND AT RANDOM TIMES. IT WAS NOTED THAT THE PATIENT IS IN THE BEGINNING STAGES OF DEMENTIA AND THE REPORTER WAS NOT CERTAIN THAT THE SOUNDS WERE COMING FROM THE DEVICE. FOLLOW UP WAS CONDUCTED WITH THE PATIENT¿S CLINIC AND THE PATIENT HAD NOT BEEN SEEN. 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
    642269 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR 6984M ADAPTOR