BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152050 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01185
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MEDTRONIC, INC.
    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

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; MOVING THE PROGRAMMER HEAD CONNECTION WOULD CAUSE A LOSE OF TELEMETRY. CONNECTOR WAS FOUND LOOSE ON A PRINTED CIRCUIT BOARD ASSEMBLY. ANALYSIS ALSO FOUND THE RIGHT AND LEFT KEYBOARD CASE HINGES WERE BROKEN.

    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)(6).

    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 BY A SALES REPRESENTATIVE (SR) THAT THE PROGRAMMER WOULD NOT INTERROGATE A DEVICE. THE SR REPLACED THE RF HEAD, BUT THIS DID NOT FIX THE ISSUE. THE CLINIC STATED THEY HAD DIFFICULTY WITH THIS SPECIFIC PROGRAMMER IN THE PAST AND HAD TO WIGGLE THE CABLE CONNECTOR TO GET IT TO WORK. THE SR WAS ABLE TO INTERROGATE THE DEVICE USING A DIFFERENT PROGRAMMER. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252861 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090

    Patients

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