BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 1072808 · Received July 10, 2008

    Report

    Report Number
    6000094-2008-00314
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    April 24, 2008
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: PRELIMINARY ANALYSIS FOUND THAT THE DEVICE HAD NO TELEMETRY AND NO OUTPUT, CONSISTENT WITH THE REPORTED FIELD EXPERIENCE. FURTHER ANALYSIS FOUND THE BATTERY TO BE FULLY DEPLETED. WHEN EXTERNAL POWER WAS APPLIED, THE DEVICE FUNCTIONED NORMALLY. BATTERY ANALYSIS FOUND NO ANOMALIES. NO ROOT CAUSE FOR THE BATTERY DEPLETION COULD BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NO TELEMETRY; IT WAS NOT POSSIBLE TO COMMUNICATE WITH THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT STATUS WAS REPORTED TO BE OK FOLLOWING THE DEVICE REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7232CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention