BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 3992286 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14872
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A LEAD WARNING FOR THE SVC COIL. THE ICD IS CURRENTLY CONNECTED TO A COMPETITOR SINGLE COIL RIGHT VENTRICULAR (RV) LEAD, WITH NO SVC COIL BEING UTILIZED OR IMPLANTED. FOLLOW-UP WITH THE ELECTROPHYSIOLOGIST REVEALED THERE WAS NO CONCERN REGARDING THE ICD PERFORMANCE. 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
    472755 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D234DRG

    Patients

    Seq Age Sex Outcome Treatment
    1