BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 1922056 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05847
    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

    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 ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE VENTRICLE WAS NOT CAPTURED AT THE SAME THRESHOLD VALUE BY THE DEVICE AS IT WAS VIA THE ANALYZER. MULTIPLE MEASUREMENTS WERE MADE WITH THE SAME RESULT. THE PHYSICIAN OPTED TO IMPLANT ANOTHER DEVICE WHICH HAD MEASUREMENTS THAT WERE CLOSER TO THE ANALYZER MEASUREMENTS. THE DEVICE WAS REMOVED AND NOT USED. 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 58 YR Other