BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO VR

    MDR report key: 2810680 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05919
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    February 13, 2013
    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). THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY VOLTAGE - PRE/APPROACHING ERI: WEEKLY BATTERY VOLTAGE TREND DATA IN SAVE TO DISK FILE (B)(4) SHOWS MIN BAT=2.93 TO 2.69 VOLTS BETWEEN (B)(6) 2012 AND (B)(6) 2012 IS BEFORE DEVICE RRT <= 2.62 VOLT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BATTERY VOLTAGE EXHIBITED A SUDDEN DECREASE IN LESS THAN A YEARS TIME. IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BATTERY VOLTAGE EXHIBITED A SUDDEN DECREASE IN LESS THAN A YEARS TIME. 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
    1 VIRTUOSO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL, INC. D154VWC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| R 7120 COMPETITOR IMPLANTABLE TACHY LEAD