BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 2203121 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04152
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    January 8, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 FOR (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 OCCURRED. WRITE TO LOCKED RAM POR WITH ECC-LIA CONFLICT, ADDRESS 6B6B, DATA 83 ON (B)(6) 2011. PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POWER ON RESET. THE DIAGNOSTIC DATA CLEARED AND THERE WERE NO PARAMETER CHANGES. IT WAS NOTED THAT THE PATIENT HAS NOT RECEIVED ANY RADIATION THERAPY AND DOES NOT RECALL BEING AROUND ANY ELECTRICAL MAGNETIC INTERFERENCE ON THE DAY OF THE RESET. THE DEVICE IS STILL 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 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD