BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO

    MDR report key: 3990110 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-14484
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCTS: 5076-45 LEAD IMPLANTED: 2009 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LONGEVITY PERFORMANCE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SHORTER THAN EXPECTED. 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
    464952 VIRTUOSO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R 694758 LEAD