BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3153758 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01467
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 16, 2013
    Manufacturer
    RICE CREEK MFG.
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (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 COULD NOT CONFIRM THE REPORTED EVENT. THE PROGRAMMER PASSED ALL FUNCTIONAL AND SYSTEMS TESTING. NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SALES REPRESENTATIVE (SR) THAT THE PROGRAMMER HAD A "NOISY" ELECTROCARDIOGRAM (ECG) DUE TO A LOOSE CONNECTOR. IT WAS ALSO REPORTED DIFFERENT ECG CABLES DID NOT HELP. THE PROGRAMMER WILL BE RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE PROGRAMMER WAS RETURNED FOR SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255282 CARELINK PROGRAMMER, PACEMAKER KRG RICE CREEK MFG. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1