BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO DR

    MDR report key: 2050738 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01477
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED BATTERY DEPLETION (ERI) WAS INDICATED ON (B)(4)-2010. A PATIENT ALERT FOR LOW BATTERY VOLTAGE OCCURRED ON (B)(4)-2010 AND THE WEEKLY LOG BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.64 TO 2.61 VOLTS BETWEEN (B)(4)-2010 AND (B)(4)-2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN UNEXPECTED DROP IN THE DEVICE BATTERY VOLTAGE. THE DEVICE BATTERY PREMATURE DEPLETED AND THE DEVICE INDICATED ELECTIVE REPLACEMENT [ERI]. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| 0158 COMPETITOR IMPLANTABLE TACHY LEAD