BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO II DR

    MDR report key: 2790272 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05498
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD VENTRICULAR TACHYCARDIA AND THE THERAPY WAS WITHHELD BY THE SINUS TACHYCARDIA RULE. THE POSSIBILITY OF REPROGRAMMING TO TRY TO AVOID THIS WAS BEING CONSIDERED BUT NOT IMPLEMENTED. NO FURTHER PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO II DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D274DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD