BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 2811049 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05942
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. UNDEFINED RESISTANCE WAS NOTED. THE WEEKLY LOG DATA IN SAVE TO DISK FILE (B)(4) SHOW 58 WEEKS OF MISSING IMPEDANCE MEASUREMENT DATA FOR MINIMUM AND MAXIMUM ATRIAL PACE BIPOLAR IMPEDANCE BETWEEN (B)(4) 2011 AND (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HISTOGRAM DATA AND THE QUICK LOOK DO NOT SHOW THE PACING PERCENTAGE INFORMATION. THE SAVE TO DISK WAS REQUESTED FOR EVALUATION OF THE ISSUE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN NOTED 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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD