BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2951716 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00082
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 13, 2012
    Report Date
    November 13, 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 THE REPORTED EVENT, THE PRINTED CIRCUIT BOARD (PCB) WAS OUT OF ELECTRICAL SPECIFICATION. AS A RESULT THE PCB WAS REPLACED AND CALIBRATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN HAD DIFFICULTY INTERROGATING AN IMPLANTABLE DEVICE. THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD WAS CHANGED, BUT THE SAME PROBLEM OCCURRED. A SOFTWARE-RELATED ISSUE WAS SUSPECTED. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56476 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