BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA DR

    MDR report key: 2791115 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05522
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 16, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S211
    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. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE CHANGE-OUT PROCEDURE, THE THRESHOLD MEASUREMENT WAS HIGH WHEN THE LEAD WAS CONNECTED TO THE NEW IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD). THE LEAD WAS CONNECTED TO THE ANALYZER AND THE THRESHOLD MEASUREMENTS WERE NORMAL. THE LEAD WAS RECONNECTED TO THE HEADER OF THE ICD AND THE THRESHOLD WAS STILL HIGH. IT WAS ALSO NOTED THAT THE "SCREW WAS NOT VISIBLE IN HEADER BARREL." THE ICD WAS NOT IMPLANTED. THE PHYSICIAN REQUESTED ANOTHER ICD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D334DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other