BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3871442 · Received June 13, 2014

    Report

    Report Number
    1000165971-2014-00347
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 29, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS OF THE RETURNED DEVICE CONFIRMED IT OPERATED AS SPECIFIED.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT WAS SEEN AT CLINIC AND A NON SUSTAINED VENTRICULAR TACHYCARDIA (VT) WAS RECORDED IN STORED EGM¿S. PATIENT WAS ADMITTED TO HOSPITAL FOR NOT FEELING WELL AND A 12 LEAD ECG SHOWED SUSTAINED PERIODS OF VT. THE 24 HOUR HEART RATE CURVE ALSO SHOWED HIGH RATES FOR ABOUT 2 HOURS ON (B)(6) 2014 BUT NO EGM TO CORRESPOND WITH IT. PHYSICIAN WAS CONCERNED THAT DEVICE DID NOT RECOGNIZE THE ARRYTHMIA. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT WAS SEEN AT CLINIC AND A NON SUSTAINED VENTRICULAR TACHYCARDIA (VT) WAS RECORDED IN STORED EGM¿S. PATIENT WAS ADMITTED TO HOSPITAL FOR NOT FEELING WELL AND A 12 LEAD ECG SHOWED SUSTAINED PERIODS OF VT. THE 24 HOUR HEART RATE CURVE ALSO SHOWED HIGH RATES FOR ABOUT 2 HOURS ON (B)(6) 2014 BUT NO EGM TO CORRESPOND WITH IT. PHYSICIAN WAS CONCERNED THAT DEVICE DID NOT RECOGNIZE THE ARRYTHMIA. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT WAS SEEN AT CLINIC AND A NON SUSTAINED VENTRICULAR TACHYCARDIA (VT) WAS RECORDED IN STORED EGM'S. PATIENT WAS ADMITTED TO HOSPITAL FOR NOT FEELING WELL AND A 12 LEAD ECG SHOWED SUSTAINED PERIODS OF VT. THE 24 HOUR HEART RATE CURVE ALSO SHOWED HIGH RATES FOR ABOUT 2 HOURS ON (B)(6) 2014 BUT NO EGM TO CORRESPOND WITH IT. PHYSICIAN WAS CONCERNED THAT DEVICE DID NOT RECOGNIZE THE ARRYTHYMIA. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349904 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2671

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R