BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 4161734 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19011
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    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
    MI, 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: 5024M-52, LEAD, IMPLANTED: (B)(6) 1996; 5071-53, LEAD, IMPLANTED: (B)(6) 2012; 4524-45, LEAD, IMPLANTED: (B)(6) 1996. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN RF (RADIO FREQUENCY) ABLATION PROCEDURE, IT WAS NOTED THAT THE PATIENT WAS IN A TACHYARRHYTHMIA. THE CLINICIAN WAS USING THE EP STUDY SCREEN (DEFIB) OF THE PROGRAMMER AND CLICKED THE "DELIVER DEFIB" BUTTON. IT WAS THEN NOTED THAT THE ARRHYTHMIA SELF-TERMINATED AT WHICH POINT THE CLINICIAN SELECTED "ABORT", BUT AFTER 10-15 SECONDS THE DEVICE STILL DELIVERED A SHOCK. IT WAS NOTED THAT THE PROGRAMMER HEAD HAD BEEN TAPED DOWN TO THE PATIENT'S CHEST WITH WIRELESS TELEMETRY TURNED OFF, PER THE CLINIC'S STANDARD PROCEDURE. IT WAS ALSO NOTED THAT AT THE TIME OF HITTING "ABORT", ABLATION WAS NOT BEING USED AND THERE WAS NO ABLATION CATHETER IN THE BODY. IT WAS FURTHER REPORTED THAT THE DEVICE LONGEVITY DID NOT LAST FOUR YEARS. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639281 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 00065 YR Hospitalization| L| R 694965 LEAD