BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3860100 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01533
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED INTERROGATION IS INTERMITTENT; MOVING THE RF (RADIO FREQUENCY) HEAD CONNECTOR MAKES TELEMETRY STOP AND START. LEM (LINK ELECTRONICS MODULE) PRINTED CIRCUIT BOARD ASSEMBLY FOUND OUT OF ELECTRICAL SPECIFICATION. ANALYSIS ALSO FOUND THE FLOPPY DRIVE IS UNABLE TO BE READ, SYSTEM FAN IS NOISY, AND STYLUS IS MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS INTERMITTENT ABILITY TO INTERROGATE DEVICES. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340564 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1