BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL 4

    MDR report key: 9673989 · Received February 5, 2020

    Report

    Report Number
    2124215-2020-03161
    Event Type
    Injury
    Date Received
    February 5, 2020
    Date of Event
    December 9, 2019
    Report Date
    February 5, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE LE K. V. AND KUSANO, K. (2019) "UNDERSENSING OF VENTRICULAR FIBRILLATION BY A BIVENTRICULAR IMPLANTABLE CARDIVERTER-DEFIBRILLATOR: WHAT IS THE CAUSE AND THE TROUBLESHOOTING?"

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING THE IMPLANT PROCEDURE FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE DEVICE UNDERSENSED A VENTRICULAR ARRHYTHMIA. THIS WAS NOTED TO BE DUE TO DISSOCIATED ACTIVATION OF THE VENTRICLES DURING VENTRICULAR TACHYCARDIA. THE DEVICE DELIVERED TACHYCARDIA THERAPY FIFTEEN SECONDS LATER, BUT DID NOT CONVERT THE ARRHYTHMIA. AN EXTERNAL SHOCK WAS DELIVERED, WHICH TERMINATED THE VT. THE PHYSICIAN ELECTED TO SWITCH THE RIGHT AND LEFT VENTRICULAR LEADS INTO THE OPPOSITE PORTS TO IMPROVE SENSING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. RECORDS INDICATE THAT THE DEVICE WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133775 CONTAK RENEWAL 4 IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION H197

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening