BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2952143 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00133
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    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 THE REPORTED EVENT; LOOSE RF (RADIO FREQUENCY) CONNECTOR FOUND ON A PRINTED CIRCUIT BOARD ASSEMBLY. PROGRAMMER SOFTWARE GAIN, ACG (AUTOMATIC GAIN CONTROL), SYSTEM A UPLINK AND TELEMETRY B UPLINK FUNCTIONAL TESTS FOUND OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS INTERMITTENT WAND CONTACT DURING INTERROGATIONS. THE PROGRAMMER AND PROGRAMMER RF (RADIO-FREQUENCY) HEAD WERE RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56906 CARELINK PROGRAM W/TELEMETRY C PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 PROGRAMMER RF (RADIO-FREQUENCY) HEAD