BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 3151790 · Received June 7, 2013

    Report

    Report Number
    9614453-2013-01086
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 21, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY, CON'T: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS DID NOT REVEAL ANY PERFORMANCE ISSUES, BUT THE CALCULATED LONGEVITY RESULT OF 82% WAS LESS THAN THE PREDICTED VALUE BASED ON THE AVAILABLE PROGRAMMED PARAMETERS. IN THE ABSENCE OF THE COMPLETE PROGRAMMING HISTORY, IT IS NOT POSSIBLE TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT OCCURRED OUTSIDE OF 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 ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS FOUND THAT THE DEVICE WAS PRE/APPROACHING THE ELECTIVE REPLACEMENT INDICATOR. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWED THE BATTERY VOLTAGE MEASUREMENTS WERE BETWEEN 2.95 VOLTS AND 2.66 VOLTS FROM (B)(6) 2012 TO (B)(6) 2013 (WHICH IS BEFORE THE DEVICE RECOMMENDED REPLACEMENT TIME OF 2.62 VOLTS). CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD, (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP VISIT, IT WAS OBSERVED THAT THE DEVICE HAD DEPLETED "RAPIDLY" FROM THE PATIENT'S PREVIOUS VISIT. IT WAS ALSO REPORTED THAT THE DEVICE MAY HAVE DEPLETED PREMATURELY. 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
    253247 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D164AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R 6949 IMPLANTABLE DEFIB LEAD