BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO

    MDR report key: 4163465 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02967
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: TROUBLESHOOTING THE MALFUNCTIONING IMPLANTABLE CARDIAC DEFIBRILLATOR. A SYSTEMATIC APPROACH. CARD.ELECTROPHYSIOL. CLIN. 2014;6(2):207-216. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIO-DEFIBRILLATOR (ICD) SYSTEM. THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS. THE ARTICLE NOTED THAT ¿PARTICULAR MOTIONS OF THE IPSILATERAL ARM OR SHOULDER COULD REPRODUCE OVERSENSING WITH VERY SHORT RR INTERVALS.¿ THERE WAS AN APPARENT LEAD FRACTURE; HOWEVER, THIS PATIENT¿S X-RAY WAS ¿NORMAL.¿ THE PATIENT HAD THE LEAD AND DEVICE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640125 VIRTUOSO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| L| R IMPLANTABLE TACHY LEAD