BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANALYST ACCEL VR, DF-4 CONNECTOR

    MDR report key: 4061837 · Received September 4, 2014

    Report

    Report Number
    2938836-2014-15497
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    July 21, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER FEELING A SHOCK. DEVICE INTERROGATION FOUND AN EPISODE OF VENTRICULAR TACHYCARDIA DETECTED AS VF. THE FIRST SHOCK WAS INEFFECTIVE, THE SECOND WAS SUCCESSFUL IN CONVERTING THE RHYTHM. THE PHYSICIAN ELECTED TO REPLACE THE DEVICE WITH ONE THAT HAD HIGHER DEFIBRILLATION ENERGY. THE DEVICE WAS EXPLANTED AND DISCARDED IN THE FIELD. THERE WERE NO ADVERSE CONSEQUENCES AND THE PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541383 ANALYST ACCEL VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1219-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention