BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 2964933 · Received February 15, 2013

    Report

    Report Number
    9614453-2013-00432
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 28, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    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 UNITED STATES, HOWEVER, IT IS THE SAME AS OR SIMILAR TO A DEVICE MARKETED IN THE U.S. (B)(4). PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE DATA SHOWS THAT THE BATTERY VOLTAGE WAS PRE/APPROACHING ELECTIVE REPLACEMENT INDICATOR (ERI). THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS THE MINIMUM BATTERY VOLTAGE EQUAL TO 2.95 TO 2.64 VOLTS BETWEEN (B)(4) 2012 AND (B)(4) 2013 WHICH IS BEFORE DEVICE RECOMMENDED REPLACEMENT TIME (RRT) OF LESS THAN OR EQUAL TO 2.62 VOLTS.

    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 THE DEVICE HAD PREMATURE BATTERY DEPLETION. THE DEVICE WILL BE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68705 VIRTUOSO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D164VWC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R