BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 2813284 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06143
    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
    AZ, US
    Reporter Occupation
    OTHER

    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 THE PATIENT CALLED INTO PATIENT SERVICES WITH A "BUZZING SOUND" ON AND OFF AND THEN REPEATING AFTER ABOUT FORTY MINUTES. DURING THE CALL PATIENT SERVICES HEARD THE PATIENT ALERT TONE BUT THE PATIENT COULD NOT, BUT DID FEEL BUZZING WHEN THEY TOUCHED THE DEVICE AREA. THE PATIENT WAS ENCOURAGED TO OBTAIN PHYSICIAN FOLLOW UP. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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 73 YR Other 6945 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD