BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151965 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01213
    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
    JA
    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. PRODUCT ID: 2090 PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE RADIO FREQUENCY (RF) PROGRAMMER HEAD WAS RETURNED AND ANALYSIS DID CONFIRM THE PHENOMENON OF TELEMETRY FAILURE AND REPLACED THE PROGRAMMER HEAD CABLE AND REPLACED THE LABEL WAS WELL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS TELEMETRY FAILURE. THE PROGRAMMER AND RF (RADIO FREQUENCY) HEAD WERE RETURNED FOR REPAIR AND CALIBRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS TELEMETRY FAILURE. THE PROGRAMMER AND RF (RADIO FREQUENCY) HEAD WERE RETURNED FOR REPAIR AND CALIBRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT MANUFACTURER'S ANALYSIS FOUND THE PROGRAMMER WITHIN SPECIFICATION AND NO ANOMALIES WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252423 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1