BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2458066 · Received February 16, 2012

    Report

    Report Number
    6000144-2012-01423
    Event Type
    Injury
    Date Received
    February 16, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED BATTERY DEPLETION WAS INDICATED (ERI). THERE WAS A CHARGE TIME > 30 SEC, AND DEVICE END OF SERVICE(EOS) > 16 SECOND CHARGE TIME AT (B)(6) 2011 21:05:15. THERE WAS 1 - PATIENT ALERT FOR EXCESSIVE CHARGE TIME ON (B)(6) 2011 21:05:15, AND 1 - PATIENT ALERT FOR CHARGE CIRCUIT TIMEOUT ON (B)(6) 2011 21:01:13. THE LAST BATTERY MEASUREMENT= 2.61 VOLTS ON (B)(6) 2011 11:55:20. THERE WAS ALSO HIGH RESISTANCE/IMPEDANCE WITH 3 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE BETWEEN (B)(6) 2009 02:15:02 AND (B)(6) 2010 02:15:02. IN ADDITION, THE DATA SHOWED 3 - ALERTS FOR SVC DEFIB LEAD IMPEDANCE = 102 OHMS BETWEEN (B)(6) 2009 AND (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MANY SHOCKS FOR ATRIAL FIBRILLATION. A CHARGE CIRCUIT TIMEOUT HAD OCCURRED AS THE DEVICE IS AT END OF SERVICE. THE DEVICE REMAINS IN USE AT THE TIME OF THE REPORT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD