BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO DR

    MDR report key: 1790996 · Received August 10, 2010

    Report

    Report Number
    6000094-2010-01462
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    March 25, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) ANALYSIS REVEALED THAT CURRENT DRAIN LEVEL WAS HIGHER THAN NORMAL FOR THIS DEVICE AND THE CAUSE OF THE EARLY BATTERY DEPLETION. HIGH LEAKAGE CURRENT THROUGH TANTALUM BATTERY FILTER CAPACITOR CAUSED THE HIGH LEAKAGE CURRENT.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7278 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 6940 IMPLANTABLE PACING LEAD| 6945 IMPLANTABLE TACHY LEAD