BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2965033 · Received February 15, 2013

    Report

    Report Number
    2182208-2013-00417
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    November 28, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWS
    PMA / PMN Number
    P980016
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN OBSERVATION THAT SEVERAL VIRTUOSO DEVICES ARE NOT LASTING AS LONG AS EXPECTED. THE CALLER DID NOT HAVE ANY SPECIFIC SERIAL NUMBERS OR PATIENT INFORMATION; THEREFORE IT IS UNKNOWN IF THERE WERE ANY PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69025 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS RICE CREEK MFG D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R