BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 3153428 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01140
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 10, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. (B)(4).

    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. A 6932 IMPLANTABLE TACHY LEAD, (B)(6) 2000. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE WAS 2.71 VOLTS TWO MONTHS AGO AND WAS NOW 2.62 VOLTS. RECOMMENDED REPLACEMENT TIME (RRT) HAD NOT TRIGGERED YET. PREMATURE BATTERY DEPLETION WAS SUSPECTED. REPLACEMENT OF THE DEVICE IS PLANNED. NO PATIENT COMPLICATIONS HAVEBEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256676 VIRTUOSO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D164VWC

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R