BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPHIR II

    MDR report key: 1596417 · Received February 9, 2010

    Report

    Report Number
    6000095-2010-00002
    Event Type
    Injury
    Date Received
    February 9, 2010
    Manufacturer
    VITATRON MEDICAL B.V.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT'S INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS SEEN FOR HER PLANNED 3-MONTH FOLLOW-UP AND UPON INTERROGATING THE DEVICE, IT WAS FOUND THERE WAS NO TELEMETRY OR MAGNET RESPONSE. THE PATIENT, WHO IS PACER DEPENDENT, HAD A HEART RATE OF 42 BPM. NO OUTPUT ALSO REPORTED. PATIENT WAS ADMITTED TO HOSPITAL AND THE PACEMAKER REPLACEMENT IS IMMINENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAPHIR II IMPLANTABLE PULSE GENERATOR DXY VITATRON MEDICAL B.V. 620 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5038 IMPLANTABLE PACING LEAD