BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 1802659 · Received August 17, 2010

    Report

    Report Number
    6000144-2010-04198
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    June 11, 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
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ICD CHANGOUT, THE SET SCREW IN THE NEW DEVICE WAS STRIPPED. A NEW SET SCREW WAS INSERTED. THE DEVICE IS CURRENTLY IMPLANTED. 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 78 YR Other 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD