BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2173004 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10308
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    May 3, 2011
    Report Date
    June 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE CURRENTLY BEING MADE TO OBTAIN MORE INFORMATION ON THIS CLINICAL OBSERVATION. ONCE ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS PACEMAKER FLATLINED WHILE IN THE RECOVERY ROOM FOLLOWING THE IMPLANTATION PROCEDURE. THE DEVICE HAD BEEN PREVIOUSLY PACING AT 60 BEATS PER MINUTE (BPM). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S501

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 4076| 4470| S501