BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO

    MDR report key: 3862146 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11107
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. EVIDENCE OF CLIPPING IN WAVELET. NO EVIDENCE OF DEVICE ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT GOT INAPPROPRIATE SHOCKS FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) WHEN THE DEVICE HAD PREVIOUSLY WITHHELD THERAPY FOR OTHER SVT EPISODES THAT LOOKED SIMILAR. THE ARRHYTHMIC SIGNAL ON THOSE EPISODES HAD EXCEED THE PROGRAMMED RANGE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341981 VIRTUOSO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154VWC

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Life Threatening 0180 BOSTON SCIENTIFIC LEAD