BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA

    MDR report key: 1850244 · Received October 1, 2010

    Report

    Report Number
    2124215-2010-16644
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO FURTHER INFORMATION AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT WITH THIS CHRONIC PACEMAKER WAS SYNCOPAL. A HEALTH CARE PROFESSIONAL (HCP) CONTACTED OUR COMPANY REQUESTING A DEVICE INTERROGATION. THE ORIGIN OF THE SYNCOPE HAS NOT BEEN DETERMINED AT THIS TIME. OUR RECORDS SHOW THIS DEVICE WAS IMPLANTED SEVENTEEN YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA IMPLANTABLE PULSE GENERATOR NVZ HISTORICAL CPI ST. PAUL 0937

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Life Threatening 0937| 4261| 4269