BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 1924406 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06134
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 18, 2010
    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
    IL, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE CAREALERTS WERE TRIGGERED ON THE SAME DAY AT THE SAME TIME. THE FIRST WAS FOR NO IMPEDANCE MEASUREMENT TAKEN FOR THE RIGHT VENTRICULAR PACING LEAD, THE SECOND WAS FOR NO IMPEDANCE MEASUREMENT TAKEN ON THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD, AND THE THIRD WAS FOR NO IMPEDANCE MEASUREMENT TAKEN ON THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION LEAD. 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 65 YR Other 7041 COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| 6726 IMPLANTABLE LEAD ADAPTOR| 6996 IMPLANTABLE TACHY LEAD