BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3279894 · Received August 10, 2013

    Report

    Report Number
    3004209178-2013-13896
    Event Type
    Injury
    Date Received
    August 10, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    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: 4076 IMPLANTABLE PACING LEAD, (B)(6) 2013; 4296 IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT INFORMATION WAS NOT BEING DISPLAYED (THERE WERE ZEROS ON THE PATIENT INFORMATION SCREENS). IT WAS ALSO REPORTED THAT THE PATIENT WAS UNDERGOING RADIATION THERAPY, AS THE CHARGED PARTICLES FROM THE RADIATION CAUSED A SINGLE BIT TO "FLIP" IN THE NON-CRITICAL DIAGNOSTIC MEMORY CORRUPTING THE PATIENT DATA. REPROGRAMMING WAS PERFORMED AND 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
    384293 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 00078 YR Required Intervention 6947M IMPLANTABLE DEFIB LEAD