BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2131867 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03498
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 29, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    Z-0128-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY FOR (B)(4): THE DEVICE WAS FOUND TO HAVE NO TELEMETRY AND NO OUTPUT AT PRELIMINARY ANALYSIS. DEVICE HAD NO TELEMETRY AND NO PACING OUTPUT DUE TO A HIGH CURRENT DRAIN CONDITION WHICH CAUSED THE BATTERY TO BECOME COMPLETELY DEPLETED. THE CAUSE OF THE HIGH CURRENT DRAIN CAN BE ATTRIBUTED TO THE CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED AT TIME OF CHANGE-OUT SO IT WAS NOT POSSIBLE TO COMMUNICATE WITH THE DEVICE PRIOR TO EXPLANT. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 68 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD