BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 2810601 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05912
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 6, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 AND ANALYZED. NO ANOMALIES WERE FOUND. THE SETSCREW WAS LOOSE/DETACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE VENTRICULAR SET SCREW ON THE DEVICE COULD NOT BE LOCATED WITH THE WRENCH. THE DEVICE DID NOT LOOK OR FEEL LIKE THERE WAS A HOLE. THE WRENCH SIMPLY GOES AROUND IN A CIRCLE WHEN PUSHED DOWN TO WHERE THE HOLE FOR THE SET SCREW SHOULD BE. THE DEVICE WAS NOT USED FOR THE PROCEDURE. ANOTHER DEVICE WAS IMPLANTED INSTEAD. 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. D204DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other