BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3151579 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01146
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, PRESSURE HAD TO BE PUT ON THE RADIOFREQUENCY (RF) CONNECTOR TO GET INTERMITTENT TELEMETRY. THE PRINTED CIRCUIT BOARD ASSEMBLY WAS LOOSE. CONCOMITANT PRODUCTS: PRODUCT ID 2067 RADIOFREQUENCY HEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT COMMUNICATION WAS UNABLE TO BE MAINTAINED BETWEEN THE PROGRAMMER AND THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD. PRESSURE HAD TO BE PUT ON THE RF HEAD CONNECTOR ON THE PROGRAMMER TO GET INTERMITTENT TELEMETRY. AT TIMES, IT TOOK 5-8 SECONDS TO GET IT TO WORK. THE RF HEAD WAS REPLACED, BUT THE ISSUE CONTINUED, AND TWO DIFFERENT RF HEADS WORKED FINE ON ANOTHER PROGRAMMER. 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
    253085 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1