BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 1792417 · Received August 11, 2010

    Report

    Report Number
    6000144-2010-03249
    Event Type
    Injury
    Date Received
    August 11, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    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

    THE PATIENT'S SPOUSE REPORTED THE PATIENT NEEDED TO GO "BACK INTO SURGERY DUE TO AN ALARM THAT WENT OFF" FROM THE DEVICE. IT WAS STATED "THERE WAS A SCREW LOOSE". FROM FOLLOWUP NOTES, IT STATES THAT THE SET SCREW HAD NOT BEEN TIGHTENED SUFFICIENTLY. THE DEVICE REMAINS 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 78 YR Required Intervention 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD