BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 2812959 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06464
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    Z-0115-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. STD REVIEW - LEAD INTEGRITY ALERT TRIGGERED. 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012 21:51:34. SENSING - OVERSENSING. 1 - VENTRICULAR NST=210 MS ON (B)(6) 2012 AT 12:13:47.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) TRIPPED. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD OVERSENSING. IT WAS ALSO LATER NOTED THAT IT WAS SUSPECTED THAT THE LIA WAS INVALID AND DUE TO ATRIAL FIBRILLATION. THE RV LEAD AND THE DEVICE REMAIN 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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other 5076 IMPLANTABLE PACING LEAD