BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 2955422 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00294
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    April 16, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4) PERFORMANCE DATA WAS COLLECTED AND ANALYZED. THE SAVE TO DISK PRIMARY FINDING NOTED DEVICE ALERT LOW BATTERY VOLTAGE RECOMMENDED REPLACEMENT TIME (RRT). TIME OF RRT IN SAVE TO DISK ON (B)(6) 2012 DEVICE RRT<(><<)>=2.62 VOLTS. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2012. TWO LOW BATTERY VOLTAGE ALERTS ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE U.S., HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4). THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR WITH SHORTER THAN EXPECTED LIFETIME LONGEVITY. THE DEVICE WAS EXPLANTED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58843 VIRTUOSO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D164VWC

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R