BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2952010 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00079
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    January 17, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4): INITIALLY THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED THE TIME OF RRT WAS ON (B)(6) 2012, WHEN THE DEVICE BATTERY VOLTAGE INDICATED ELECTIVE REPLACEMENT AND WAS LESS THAN OR EQUAL TO 2.62 VOLTS. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWED A BATTERY VOLTAGE EQUAL TO 2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2012. TWO LOW BATTERY VOLTAGE ALERTS WERE TRIGGERED ON (B)(6) 2012. CONCOMITANT PRODUCT: 6947 IMPLANTABLE TACHY LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD UNEXPECTED BATTERY LONGEVITY BECAUSE ELECTIVE REPLACEMENT (ERI) WAS INDICATED AFTER ONLY 4.5 YEARS OF SERVICE. 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
    57608 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D164AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R 1788TC COMPETITOR IMPLANTABLE PACING LEAD