BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2951895 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00103
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    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

    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

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THAT THE ELECTROCARDIOGRAM (ECG) CONNECTOR WAS LOOSE, THE ECG SIGNAL WAS NOISY. IT WAS ALSO NOTED THAT THE POWER CORD BAY WAS BROKEN, THE KEYBOARD HINGES WERE BROKEN, AND THE SYSTEM FAN WAS INTERMITTENTLY NOISY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTROCARDIOGRAM (ECG) CONNECTOR WAS NOT WORKING. THE PROGRAMMER WAS SUBSEQUENTLY RETURNED WITH A REPORT THAT THE ECG WAS UNCLEAR, AND MANIPULATING THE CABLE/PROGRAMMER CONNECTION, AS WELL AS TRYING NEW CABLES/PATCHES, DID NOT RESOLVE THE ISSUE. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56761 CARELINK PROGRAM W/TELEMETRY C PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1