BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 1991042 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00817
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND THE CAUSE OF THE EARLY BATTERY DEPLETION IN THIS DEVICE WAS IDENTIFIED AS HIGH CURRENT LEAKAGE IN THE C46 CAPACITOR. THE EARLY BATTERY DEPLETION WAS DUE TO A HIGH CURRENT DRAIN CONDITION IN THE HYBRID. ANALYSIS OF THE HYBRID CONFIRMED HIGH CURRENT LEAKAGE IN THE C46 CAPACITOR.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT) EARLIER THAN EXPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE ATTORNEY ALLEGES THE PATIENT "WITHOUT WARNING, EXPERIENCED INAPPROPRIATE SHOCKS" FROM THE RIGHT VENTRICULAR LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT) EARLIER 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
    1 VIRTUOSO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VWC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 6947 IMPLANTABLE TACHY LEAD