BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2951754 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00086
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, NO ANOMALIES WERE FOUND WITH THE PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER FAILED TO INTERROGATE DEVICES. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER FAILED TO INTERROGATE DEVICES. THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE RETURNED FOR REPAIR. THE RADIOFREQUENCY (RF) HEAD WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OFTHIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57338 CARELINK PROGRAM W/TELEMETRY C PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090W

    Patients

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