BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3860154 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-10618
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. PRODUCTS: 6949-65 LEAD IMPLANTED: 2006 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE APPROPRIATE SHOCKS AND ANTI-TACHYCARDIAC PACING FOR FAST VENTRICULAR TACHYCARDIA. THE PHYSICIAN BELIEVED THAT THE DEVICE INAPPROPRIATELY CLASSIFIED THE EPISODES AS NON-SUSTAINED DUE TO THE IRREGULARITY OF THE VENTRICULAR RHYTHM. THE DISSOCIATED RHYTHM INTERVALS CAUSED THE DEVICE TO RESET VENTRICULAR TACHYCARDIA (VT) DETECTION SO NO VT THERAPIES WERE ATTEMPTED WHICH DELAYED TREATMENT. 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
    337054 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR 5076-52 LEAD