BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3152090 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-08792
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 2, 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
    MD, 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. CONCOMITANT PRODUCTS: PRODUCT ID 693158 IMPLANTABLE TACHY LEAD IMPLANTED: (B)(6) 2007, PRODUCT ID 419378 IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2007, 5076 IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE EMERGENCY ROOM (ER) UPON HEARING AN ALERT TRIGGERED FOR HIGH IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS ALSO HIGH IMPEDANCE ON THE LEFT VENTRICULAR (LV) LEAD. IT WAS NOTED THERE WAS A LOOSE SET SCREW. THE PATIENT REQUIRED SURGICAL INTERVENTION TO ASSESS SET SCREW. THE DEVICE AND LEADS REMAIN 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
    252938 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 00077 YR Hospitalization| R