BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2954711 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02113
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 7, 2012
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 6944 IMPLANTABLE DEFIB LEAD (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY CERAMIC CAPACITORS. THE DEVICE MET 50% OF THE EXPECTED LONGEVITY.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS SURPRISED THAT THE BATTERY IN THE DEVICE ONLY LASTED 4 YEARS. IT WAS ALSO REPORTED THAT THE ALERT TRIGGERED BUT COULD NOT BE HEARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED EARLY BATTERY DEPLETION. 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
    59408 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD