BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRINSIC

    MDR report key: 2609390 · Received June 11, 2012

    Report

    Report Number
    6000144-2012-03327
    Event Type
    Injury
    Date Received
    June 11, 2012
    Date of Event
    December 9, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S041
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE DEVICE RECORDED ONE POWER ON RESET (POR) FOR CRITICAL RANDOM ACCESS MEMORY (RAM) PARITY ERROR, ADDRESS EQUALING (B)(4), DATA EQUALING 66 ON (B)(6) 2011 09:03:11. THERE WAS ONE PATIENT ALERT FOR THE POR ON (B)(6) 2011 09:03:11.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) RESET. IT WAS NOTED THAT THE PATIENT WAS RECEIVING RADIATION THERAPY. THE ICD WAS REPROGRAMMED AND 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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention 4068 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD