BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 1863111 · Received October 9, 2010

    Report

    Report Number
    6000144-2010-05011
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    June 21, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A SHOCK SUDDENLY DUE TO ELECTROMAGNETIC INTERFERENCE (EMI). THE PATIENT REPORTED NO SYMPTOMS PRECEDING SHOCK AND STATES IT FELT LIKE HE WAS "HIT IN THE HEAD WITH A SLEDGEHAMMER AND AN ICE PICK TO THE CHEST" AND HE WAS "WEAK/WASHED OUT" THE REST OF THE DAY. THE DEVICE IS STILL IN USE. NO FURTHER 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 84 YR Other 5076 IMPLANTABLE PACING LEAD| 0181 NON-MEDTRONIC IMPLANTABLE TACHY LEAD