BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3050952 · Received April 10, 2013

    Report

    Report Number
    2182208-2013-01036
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 23, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    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 NOISY ELECTROCARDIOGRAM (ECG) SIGNAL AND ATTRIBUTED IT TO A LOOSE ECG CONNECTOR. ANALYSIS COULD NOT CONFIRM THE REPORTED ERROR. ANALYSIS DID FIND A NOISY SYSTEM FAN WHICH WAS REPLACED. NO OTHER ANOMALIES WERE FOUND. CONCOMITANT PRODUCTS: PRODUCT ID 2067 RADIO FREQUENCY PROGRAMMER HEAD. (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. (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 THERE WAS A NOISY SIGNAL ON THE PATIENT ECG (ELECTROCARDIOGRAM). IT WAS ALSO REPORTED THERE WAS A SYSTEM TEST FAILURE MESSAGE. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A NOISY SIGNAL ON THE PATIENT ECG (ELECTROCARDIOGRAM). IT WAS ALSO REPORTED THERE WAS A SYSTEM TEST FAILURE MESSAGE. 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
    148912 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1