BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3153782 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08944
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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 RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. CONCOMITANT PRODUCTS: PRODUCT ID 4296, IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE AFTER INITIALLY PLACING THE LEFT VENTRICULAR (LV) IMPLANTABLE PACING LEAD THE LEAD BECAME DISLODGED AND REQUIRED REPOSITIONING. ATTEMPTS TO REPOSITION THE LEAD WERE UNSUCCESSFUL AND A NEW LEAD AND GUIDEWIRE WERE USED. ADDITIONALLY, AFTER SUCCESSFULLY OBTAINING LEAD ELECTRICAL MEASUREMENTS THROUGH THE ANALYZER ALL LEADS WERE CONNECTED TO THE IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEVICE BUT PROPER PACING COULD NOT BE REPRODUCED THROUGH THE LV LEAD. ATTEMPTS TO CORRECT THE ISSUE WERE UNSUCCESSFUL. A NEW DEVICE WAS REQUESTED AND IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255384 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 00080 YR