BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2290491 · Received October 12, 2011

    Report

    Report Number
    3004593495-2011-00162
    Event Type
    Malfunction
    Date Received
    October 12, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 12, 2011
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S173
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS ANALYZED AND THE REPORTED EVENT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE ACCESSORY HAS BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE E-DEVICE CELLULAR ACCESSORY "STOPPED WORKING." THE PATIENT IS SENDING IN THE E-DEVICE CELLULAR ACCESSORY, AND A NEW ONE IS BEING SENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ PLEXUS MANUFACTURING SDN. BHD MLINK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other 6947 IMPLANTABLE TACHY LEAD| D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD