BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 2051988 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01562
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 3, 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
    NC, 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 DEVICE WAS RETURNED, ANALYZED, AND THE ANALYSIS REVEALED NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE DEVICE CHANGEOUT PROCEDURE, THE CHRONIC, COMPETITIVE RIGHT VENTRICULAR LEAD HAD NORMAL MEASUREMENTS THROUGH THE ANALYZER BUT WHEN CONNECTED TO THE DEVICE THE IMPEDANCE WAS NOT IN MEASURABLE RANGE AND THERE WAS NO PACING OR SENSING. IT WAS CONFIRMED THAT THE SET SCREW WAS NOT FUNCTIONAL. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS WERE 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 47 YR Other 0181 COMPETITOR IMPLANTABLE TACHY LEAD