BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK SYSTEM

    MDR report key: 2292385 · Received October 13, 2011

    Report

    Report Number
    2182208-2011-02249
    Event Type
    Malfunction
    Date Received
    October 13, 2011
    Date of Event
    March 31, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRANSMISSIONS HAD FAILED, INDICATING THEY COULD NOT BEEN SEEN ON THE SITE. THE MONITOR HAD SUCCESSFULLY SENT TRANSMISSIONS PREVIOUSLY. FURTHER INVESTIGATION INDICATED THAT THE PATIENT SHOULD ENSURE CLOSE PROXIMITY WITH THE MONITOR AND E-DEVICE CELLULAR ACCESSORY WHILE SLEEPING AND ANY POTENTIAL INTERFERENCES ARE REMOVED. THE REMOTE MONITOR AND E-DEVICE CELLULAR ACCESSORY APPEAR TO REMAIN IN SERVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK SYSTEM SOFTWARE NVZ MEDTRONIC, INC. CARELINK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UNKNOWN IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB