BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 1922021 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05841
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 14, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO ANOMALIES FOUND UPON ANALYSIS. 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 NO ANOMALIES WERE FOUND. THERE WAS A SET SCREW IN THE CONNECTOR BORE. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) MALFUNCTIONED DURING IMPLANT. THE ICD'S SETSCREW WAS STRIPPED AND THE "WRENCH WILL NOT ENGAGE". ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED. 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 75 YR Other 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD