BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT VR RF

    MDR report key: 3854622 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11475
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO DIZZINESS AND PALPITATIONS. DURING DEVICE INTERROGATION, SEVERAL VENTRICULAR FIBRILLATION AND VENTRICULAR TACHYCARDIA EPISODES WERE OBSERVED. THE PATIENT RECEIVED MULTIPLE APPROPRIATE AND INAPPROPRIATE SHOCKS. DFT WAS HIGH CAUSING SOME SHOCKS TO BE INEFFECTIVE. PROGRAMMING CHANGES WERE MADE. PATIENT CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332119 CURRENT VR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R