BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSAR MAX II

    MDR report key: 2041718 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-04501
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED AND REPLACED IN (B)(6) 2011 DUE TO NORMAL BATTERY DEPLETION. THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS PATIENT'S DEVICE IS "ONE TICK ABOVE ERT AND SHOWING LESS THAN 0.5 YEARS". WHEN THE MINUTE VENTILATION (MV) FEATURE WAS PROGRAMMED ON, THE DEVICE REPORTED GREATER THAN 5.0 YEARS. TECHNICAL SERVICES SUGGESTED THAT THE MV SHOULD NOT BE PROGRAMMED ON WITH THE CURRENT BATTERY STATUS INDICATOR (LESS THAN 10% CAPACITY REMAINING) AS THIS COULD HAVE A NEGATIVE EFFECT ON ELECTIVE REPLACEMENT INDICATOR (ERI) AND END-OF-LIFE (EOL) TRIGGERS. ADDITIONALLY, THE LOCAL REPRESENTATIVE REPORTED THAT THE PATIENT EXPERIENCED A DIZZY SPELL AND FELL. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE PATIENT MAY UNDERGO A DEVICE REPLACEMENT PROCEDURE. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED IN (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX II IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1280

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization 4285| 4016| 1280