BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3051211 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05929
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 4542 COMPETITOR IMPLANTABLE PACING LEAD 2012-(B)(6); 4076 IMPLANTABLE PACING LEAD 2012-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT "SOMETHING IS WRONG WITH THE ADJUSTMENT OF THE DEVICE." THE PATIENT NOTED THAT THEIR HEART RATE IS APPROXIMATELY 120 TO 130 BEATS PER MINUTE AND "IT DOESN'T FEEL RIGHT." MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. 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
    149242 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 00070 YR 6947M IMPLANTABLE DEFIB LEAD