BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152490 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01550
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    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 CUSTOMER COMMENT THAT THE ELECTROCARDIOGRAM (ECG) INPUT WAS VERY NOISY AND THAT THE RADIO FREQUENCY (RF) HEADER INPUT HAD INTERMITTENT TROUBLE WITH TELEMETRY (EVEN WITH MULTIPLE PROGRAMMER HEADS TRIED). THE LINK ELECTRONIC MODULE (LEM) BOARD WAS REPLACED AND CALIBRATED DUE TO THE LOOSE RF AND ECG CONNECTORS. ANALYSIS ALSO FOUND THAT THE KEYBOARD WAS BROKEN AND THE SYSTEM FAN WAS NOISY, BOTH WERE REPLACED. CONCOMITANT PRODUCTS: PRODUCT ID 2067 RADIO FREQUENCY PROGRAMMER HEAD; PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT ID 2067 RF HEAD PRODUCT ID 229047 ANALYZER. (B)(4).

    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 REPORTED THAT THE PROGRAMMER SHOWED A LOT OF "NOISE" ON THE ELECTROCARDIOGRAM (EKG) PLUG AND "ISSUES" WITH THE RADIOFREQUENCY (RF) HEAD CONNECTOR. ADDITIONAL INFORMATION OBTAINED THROUGH FOLLOW UP WITH THE COMPANY REPRESENTATIVE INDICATED THAT MULTIPLE RF HEADS WERE TRIED, AND SOMETIMES THE CORD PIN WOULD HAVE TO BE "JIGGLED" TO GET TELEMETRY WITH A DEVICE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER SHOWED A LOT OF "NOISE" ON THE ELECTROCARDIOGRAM (EKG) PLUG AND ISSUES WITH THE RADIOFREQUENCY (RF) HEAD CONNECTOR. ADDITIONAL INFORMATION OBTAINED THROUGH FOLLOW UP WITH THE COMPANY REPRESENTATIVE INDICATED THAT MULTIPLE RF HEADS WERE TRIED, AND SOMETIMES THE CORD PIN WOULD HAVE TO BE "JIGGLED" TO GET TELEMETRY WITH A DEVICE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252731 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1