BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO DR

    MDR report key: 3051109 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05890
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    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. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MINIMUM BATTERY VOLTAGE IS 3.0 TO 2.66 VOLTS BETWEEN (B)(6) 2012 AND (B)(6) 2013. RECOMMENDED REPLACEMENT TIME INDICATOR IS LESS THAN OR EQUAL TO 2.62 VOLTS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MINIMUM BATTERY VOLTAGE IS 3.0 TO 2.66 VOLTS BETWEEN (B)(4) 2012 AND (B)(4) 2013. RECOMMENDED REPLACEMENT TIME INDICATOR IS LESS THAN OR EQUAL TO 2.62 VOLTS. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD 2008 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE DEVICE BATTERY LONGEVITY PERFORMANCE WAS NOT COMPENSATORY WITH THE PROGRAMMED PARAMETERS AND THERAPY USAGE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153828 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR 6947 IMPLANTABLE TACHY LEAD