BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 1925271 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06262
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    April 1, 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
    FL, US
    Reporter Occupation
    PATIENT

    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 BY THE PATIENT THAT THE DEVICE SHOCKED 24 TIMES LAST APRIL AND THEN AGAIN LAST WEEK. THE PATIENT FURTHER REPORTED THAT SHE WENT TO THE ER AND WAS TOLD "DEVICE MALFUNCTIONED BUT WAS SENT HOME." THE PATIENT REPORTED THAT SHE WENT TO HER HEART DOCTOR AND THE DEVICE WAS RESET AGAIN. THE DEVICE REMAINS 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 VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VWC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R 6947 IMPLANTABLE TACHY LEAD