BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 3153086 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01122
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 18, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE FOUND A HIGH CURRENT DRAIN CONDITION DUE TO CURRENT LEAKAGE IN A CERAMIC CAPACITOR. ANALYSIS OF THE DEVICE MEMORY INDICATED LOW BATTERY VOLTAGE ALERT FOR RRT (RECOMMENDED REPLACEMENT TIME) ON (B)(4) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) AFTER 3 YEARS OF "NORMAL" USE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256005 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D164AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R