BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUNCTUA

    MDR report key: 3212492 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09159
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS REPROGRAMMED AND REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT APPROXIMATELY ONE MONTH POST IMPLANT, THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTED TO THE HOSPITAL AFTER EXPERIENCING SYNCOPAL EPISODES AND VENTRICULAR TACHYCARDIA (VT). THERE WAS CONCERN THAT THE HEART RATE WAS APPROXIMATELY 160 BPM AND THERE WAS NO DEVICE RESPONSE. IT WAS THOUGHT THIS WAS DUE TO THE PROGRAMMING RATES ABOVE THE TACHYCARDIA SO THE DEVICE DID NOT DELIVER THERAPY. BEFORE PROGRAMMING COULD BE PERFORMED, A VENTRICULAR FIBRILLATION (VF) EPISODE OCCURRED THAT WAS SUCCESSFULLY CONVERTED TO SINUS RHYTHM WITH AN EXTERNAL SHOCK. THIS DEVICE WAS REPROGRAMMED AND REMAINS IN SERVICE. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312148 PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND P052

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R