BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 2952026 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00091
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 7, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED BATTERY DEPLETION IND ICATED/ELECTIVE REPLACEMENT INDICATOR (ERI). TIME OF RECOMMENDED REPLACEMENT TIME (RRT) WAS ON (B)(6) 2012, DEVICE RRT LESS THAN OR EQUAL TO 2.62 VOLT. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MINIMUM BATTERY EQUALS 2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2012. PATIENT ALERTS FOR LOW BATTERY VOLTAGE ON (B)(6) 2012 AND (B)(6) 2012. THE DEVICE WAS SUBSEQUENTLY 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 MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE U.S., HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ALERT SOUNDED WHEN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED RECOMMENDED REPLACEMENT TIME (RRT). PREMATURE BATTERY DEPLETION IS SUSPECTED. 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
    55660 VIRTUOSO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D164VWC

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R