BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

    MDR report key: 3861735 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11163
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. THE COMPLAINT WAS RECEIVED WITHOUT A SERIAL NUMBER OR PATIENT FULL NAME; AS A RESULT, LIMITED INFORMATION WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S ICD WAS NOT RECORDING VENTRICULAR TACHYCARDIA (VT) EVENTS REQUIRING THERAPY. THE PATIENT DID NOT PROVIDE THEIR FULL NAME OR SERIAL NUMBER, SO FOLLOW UP WAS NOT POSSIBLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT AND THE DEVICE REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342069 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1