BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRINSIC

    MDR report key: 2810838 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02371
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S041
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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 (POR) WERE NOTED AS ONE POR FOR WRITE TO LOCKED RAM, ADDR=0DC4, DATA=1 OCCURRED ON (B)(6) 2012. ONE PATIENT ALERT FOR POR OCCURRED ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN ELECTRICAL RESET. THE DEVICE 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 S.A. 7288

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 6940 IMPLANTABLE PACING LEAD| 6943 IMPLANTABLE TACHY LEAD