BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY II

    MDR report key: 1850136 · Received October 1, 2010

    Report

    Report Number
    2124215-2010-14290
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    May 30, 2008
    Report Date
    July 2, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACING SYSTEM WAS EXPLANTED DUE TO EROSION. A NEW SYSTEM WAS IMPLANTED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY II IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1284

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR 4076| 4470| 1190| 4457| 1284