BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152156 · Received June 7, 2013

    Report

    Report Number
    3004593495-2013-00002
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    PLEXUS MANUTACTURING
    Product Code
    NVZ
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S CURRENT ELECTROGRAM (EGM) IN THE REMOTE WEBSITE, HAS A NON-STANDARD APPEARANCE AND MARKER CHANNELS ARE DISTORTED. THIS WAS CONFIRMED ON ALL THREE OF THE PATIENT'S REMOTE WEBSITE TRANSMISSIONS, THAT THE EGM PRESENTED WITH SQUARED FORM AND UNRELIABLE MARKER CHANNEL VALUES. HOWEVER, WHEN THE PATIENT WAS CHECKED IN THE CLINIC, VALUES WERE NORMAL. THEREFORE, THE ISSUE WAS ESCALATED TO PRODUCT SUPPORT (PS) FOR INVESTIGATION AND RESOLUTION. IT WAS FURTHER REPORTED THAT PS DETERMINED THAT CAUSATION WAS DUE TO THE REMOTE MONITOR AND BACK IN (B)(6), RECOMMENDED THAT THE MONITOR BE REPLACED AND TO HAVE THE PATIENT RE-SEND THE TRANSMISSION. IN (B)(6), THE PATIENT CONTACTED CLINIC TO ORDER A NEW MONITOR PER PATIENT SERVICES INSTRUCTIONS; THE CLINICIAN WONDERED WHY THE COMPANY DOES NOT ORDER THE NEW MONITOR. TS APOLOGIZED FOR THE LESS THAN SATISFACTORY CUSTOMER SERVICE. IN (B)(6), PS SENT A FOLLOW UP EMAIL TO INQUIRE ABOUT THE STATUS OF THE MONITOR BECAUSE IT APPEARED THAT THE CLIENT HAD NOT SUBMITTED THE NEW MONITOR ORDER. THE MONITOR WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253045 CARELINK PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ PLEXUS MANUTACTURING 2490C8

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR