BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT DR

    MDR report key: 3210645 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-11443
    Event Type
    Death
    Date Received
    July 8, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    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
    FL, 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 ID: 407652, IMPLANTED: (B)(6) 2008; PRODUCT ID: 694765, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NORMAL DEVICE REPLACEMENT THE PATIENT HAD CARDIAC ARREST. THE DEVICE WAS CONNECTED TO THE EXISTING LEADS, CARDIOPULMONARY RESUSCITATION WAS INITIATED AND SHOCKS WERE DELIVERED FOR VENTRICULAR FIBRILLATION THAT WERE SUCCESSFUL. THE PATIENT CONTINUED TO GO INTO VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION AND THE RHYTHM CHANGED TO PULSELESS ELECTRICAL ACTIVITY. IT WAS ALSO NOTED THAT THERE WAS ABRASION ON THE ATRIAL LEAD ALTHOUGH IT REMAINED ELECTRICALLY INTACT. THE PHYSICIAN APPLIED AN ADHESIVE AND SUTURE SLEEVE OVER THE ABRASION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309219 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Death