BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2010-24118

    MDR report key: 1954181 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24118
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SOME PATIENTS WITH IMPLANTABLE DEFIBRILLATORS RECEIVED ANTI-TACHYCARDIA PACING DUE TO REDETECTION WHEN THE HEART RATE STOPPED OR SLOWED DOWN. THESE PATIENTS EXPERIENCED SYNCOPE BECAUSE OF NOT RECEIVING A SHOCK DUE TO THIS PROGRAMMING FEATURE. CURRENTLY THESE DEVICE REMAIN IMPLANTED AND IN SERVICE. NO ADDITIONAL PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LWS GUIDANT PUERTO RICO BV TACHY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening 0184| N119| 4542| 4135