BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2952660 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00211
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 16, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED A LOSS OF TELEMETRY AND THAT IT WAS NOT RESOLVED WITH NEW PROGRAMMER LEADS. THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE RETURNED FOR REPAIR. BOTH PRODUCTS WERE ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO INDICATION GIVEN AS TO ANY PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55984 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1