BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2203834 · Received August 11, 2011

    Report

    Report Number
    3004593495-2011-00077
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S154
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    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. CORRECTION NOTE: THIS COMPLAINT WAS INADVERTENTLY SUBMITTED UNDER THE MEDICAL DEVICE REPORTING REGULATIONS, AS THE POTENTIAL FOR INJURY IS NOT LIKELY FOR THIS TYPE OF COMPLAINT (MANUAL TRANSMISSION) IF IT WERE TO RECUR.

    Additional Manufacturer Narrative · 1

    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 SINCE STORM, MONITOR DOES NOT DIAL OUT. REACHES SEND PHASE, BLINKS ORANGE, BUT NEVER DIALS OUT. PATIENT THINKS THE MONITOR WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PATIENT MONITORING INSTRUMENT NVZ PLEXUS MANUFACTURING SDN. BHD. 2490C8 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB