BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2607129 · Received June 11, 2012

    Report

    Report Number
    2183613-2012-00911
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Date of Event
    March 15, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    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.

    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): ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. NO ELECTRICAL ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PREVIOUSLY WORKING REMOTE MONITOR NO LONGER RESPONDED TO THE START BUTTON. THE ATTEMPT TO RESET THE MONITOR BY UNPLUGGING AND REPLUGGING IN THE POWER CORD WAS NOT SUCCESSFUL. 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
    1 CARELINK PATIENT MONITORING INSTRUMENT NVZ MEDTRONIC MILACA INC. 2490C

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB