BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3046467 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05231
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THE DEFIBRILLATION IMPEDANCE WAS OUT OF RANGE, LOW. DURING THE EPISODE VFRX1X DEFIBRILLATION PATHWAY B TO AX, HIGH VOLTAGE IMPEDANCE EQUAL TO 0 OHMS, ON (B)(6) 2013. CONCOMITANT PRODUCTS: 3830 IMPLANTABLE PACING LEAD (B)(6) 2006; ICF09B IMPLANTABLE PACING LEAD (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING A CHANGE OUT, THE DOCTOR HOOKED UP THE NEW DEVICE TO THE OLD LEADS AND WHEN DOING THE DEFIBRILLATION THRESHOLD TEST (DFT) THE DEVICE DELIVERED 0 JOULES (PROGRAMMED TO 20 JOULES). THE DEVICE CONTINUED TO RECOGNIZE THE RHYTHM, REDETECTED AND DELIVERED THE 25 JOULE SHOCK AND RESCUED THE PATIENT. 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
    150766 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS D314TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR 6947 IMPLANTABLE DEFIBRILLATOR LEAD