BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151710 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01281
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 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. CONCOMITANT PRODUCT: PRODUCT ID 2067L RADIO FREQUENCY PROGRAMMER HEAD. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED INTERMITTENT INTERROGATION, EVEN WITH A KNOWN GOOD RADIO (RF) FREQUENCY PROGRAMMER HEAD. LOOSE RF AND ELECTROCARDIOGRAM (ECG) CONNECTORS WERE FOUND ON THE LINK ELECTRONIC MODULE (LEM) BOARD, WHICH WAS REPLACED AND CALIBRATED. ANALYSIS ALSO FOUND THAT THE DISPLAY LOWERED BY ITSELF IN SOME POSITIONS AND THE LOWER LEFT AND LOWER RIGHT HINGES WERE REPLACED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ATTEMPTING INTERROGATION, THE PROGRAMMER WAS UNABLE TO RECOGNIZE IMPLANTABLE HEART DEVICES. THE PROGRAMMER HEAD WAS CHANGED OUT BUT THIS DID NOT RESOLVE THE ISSUE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ATTEMPTING INTERROGATION, THE PROGRAMMER WAS UNABLE TO RECOGNIZE IMPLANTABLE HEART DEVICES. THE PROGRAMMER HEAD WAS CHANGED OUT BUT THIS DID NOT RESOLVE THE ISSUE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252371 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1