BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRINSIC

    MDR report key: 2130122 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03311
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    December 1, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S041
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. POWER ON RESET PARAMETERS WERE OBSERVED AS ONE POWER ON RESET FOR WRITE TO LOCKED RAM OCCURRED ON (B)(6) 2010 12:36:42 AND ONE PATIENT ALERT FOR POR OCCURRED ON (B)(6) 2010 12:36:42.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ELECTRICAL RESET MESSAGE ON A CARELINK TRANSMISSION. IT WAS FURTHER REPORTED THAT THE PATIENT WAS UNDERGOING RADIATION THERAPY AT THE TIME. IT IS UNKNOWN IF THERE WAS ANY INTERVENTION. 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 INTRINSIC IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7288 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE TACHY LEAD