BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2150907 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06297
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    July 15, 2010
    Report Date
    April 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 RECEIVED INFORMATION THAT THIS PATIENT HAD BEEN EXPERIENCING A STINGING SENSATION NEAR HIS PACEMAKER POCKET. THE SENSATION WAS ONLY OCCURRING ONCE IN A WHILE FOR APPROXIMATELY ONE SECOND, TWO TO THREE TIMES PER DAY. (B)(6) LATER, IT WAS REPORTED THAT THIS PACEMAKER HAD ERODED THROUGH THIS PATIENT'S SKIN. THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)