BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4972142 · Received August 5, 2015

    Report

    Report Number
    2182208-2015-02907
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    June 21, 2015
    Report Date
    July 22, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE PROGRAMMER WOULD NOT INTERROGATE DEVICES; THE RF (RADIO FREQUENCY) HEAD CONNECTOR WAS FOUND LOOSE ON THE LEM (LINK ELECTRONIC MODULE) PRINTED CIRCUIT BOARD ASSEMBLY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER RADIO FREQUENCY (RF) PROGRAMMER HEAD WOULD NOT INTERROGATE DEVICES. IT WAS NOTED THAT IT IS A PROGRAMMER ISSUE AS MULTIPLE RF HEADS WERE ATTEMPTED TO CORRECT THE ISSUE. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519037 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1