BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2954340 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00451
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 TO THE MANUFACTURER AND ANALYZED. ANALYSIS REVEALED THAT A HIGH CURRENT DRAIN CONDITION WAS FOUND. ELECTRICAL ANALYSIS FOUND THE CAUSE OF THE HIGH CURRENT DRAIN TO BE CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. SAVE TO DISK ANALYSIS REVEALED DEVICE AT ERI (ELECTIVE REPLACEMENT INDICATOR). CONCOMITANT PRODUCTS: 5554 IMPLANTABLE PACING LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: SAVE TO DISK ANALYSIS REVEALED DEVICE AT ERI (ELECTIVE REPLACEMENT INDICATOR), AS THERE WAS AN ALERT FOR BATTERY DEPLETION INDICATED/ERI ON (B)(6) 2012 AND AN ADDITIONAL ALERT OCCURRED ON (B)(6) 2012.

    Description of Event or Problem · 1

    THE DEVICE IS SUSPECTED OF PREMATURE ELECTIVE REPLACEMENT INDICATOR (ERI). 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
    59420 VIRTUOSO DR LWS IPG MFG SWITZERLAND D164AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 6947 IMPLANTABLE TACHY LEAD