BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 7579235 · Received May 31, 2018

    Report

    Report Number
    7579235
    Event Type
    Injury
    Date Received
    May 31, 2018
    Date of Event
    May 22, 2018
    Report Date
    May 29, 2018
    Manufacturer
    ST. JUDE MEDICAL, PLANO, TX
    Product Code
    NVZ
    UDI-DI
    05414734402460
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLANNED SURGERY (B)(6) 2018 TO EXPLANT EONC 1PG DUE TO BATTERY EXHAUSTION. LEAD DISLODGEMENT OCCURRED. CASE SUSPENDED, MANUFACTURER CONTACTED REQUESTING NEW LEADS. PATIENT HOSPITALIZED WITH SURGICAL DRAINS PER ROUTINE. BATTERY EXHAUSTION, SURGICAL REPLACEMENT, LEAD DISLODGEMENT, HOSPITALIZATION NOTED AS POSSIBLE RISKS IN PROTOCOL. MANUFACTURER TOLD SPONSOR (B)(6) 2018 THAT DEVICE COMPONENTS (EONC/LIBRA DBS LEADS) BEING PHASED OUT AND NOT LOCATED TO PROVIDE TO SITE. SUGGESTED SJM INFINITY DBS SYSTEM TECHNOLOGY AND REVIEWED BY SPONSOR/TEAM/PATIENT. LATE EVENING (B)(6) 2018, PATIENT HAD ELEVATED HEART RATE. RAPID RESPONSE TEAM CALLED FOR SVT SUSTAINED RATE OF 188/CHEST TIGHTNESS. METOPROLOL ADMINISTERED, HEART RATE DOWN TO SR 88. ECG SHOWS PROBABLE LEFT VENTRICULAR HYPERTROPHY. PATIENT TO OPERATING ROOM (B)(6) 2018 FOR IMPLANTATION OF SJM INFINITY IPG/DBS LEADS, USING SWIFT LOCK ANCHORS AND SUTURES TO SECURE. SUCCESSFUL IMPLANTATION AND DOCUMENTATION OF IPG/LEAD STIMULATION OCCURRED BEFORE LEAVING OPERATING ROOM. PATIENT INITIALLY EXTUBATED POST-OP, DEVELOPED STRIDOR, REINTUBATED. TO OPERATING ROOM (B)(6) 2018 FOR EXTUBATION. SATS REMAINED LOW AND TRACHEOTOMY ULTIMATELY PERFORMED. ULTRASOUND (B)(6) 2018 NOTED NONOCCLUSIVE THROMBUS IN LEFT POPLITEAL VEIN AND CT SAME DATE NOTED DIFFUSE PULMONARY ARTERIAL EMBOLI IN BOTH DISTAL MAIN PULMONARY ARTERIES WITH EXTENSION INTO UPPER AND LOWER LOBE BRANCHES, LUNGS CLEAR. PATIENT DISCHARGED (B)(6) 2018. THE BATTERY EXHAUSTION OF DEVICE AND DELAY IN OBTAINING EQUIPMENT FOR SURGICAL IMPLANTATION COULD HAVE CAUSED STRESS TO PATIENT RESULTING IN ELEVATED HEART RATE AND STRIDOR, RESULTING IN TRACHEOTOMY. WE BELIEVE PULMONARY EMBOLISM COULD BE DUE TO LACK OF ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401745 EONC IMPLANTABLE PULSE GENERATOR NVZ ST. JUDE MEDICAL, PLANO, TX 3688 527540 05414734402460

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R