BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3153095 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01391
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 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 FOUND THAT THE STYLUS WILL NOT SELECT FROM THE TOUCH SCREEN. STYLUS FOUND OUT OF ELECTRICAL SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT ID: 2067 RF HEAD; PRODUCT ID: 229047 ANALYZER. (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 THERE WAS A TOUCH SCREEN ISSUE. FOLLOWUP INFORMATION RECEIVED INDICATES THE TOUCHSCREEN DID NOT WORK ANY OF THE TIME. IT WAS ALSO REPORTED THE PROGRAMMER WAS RETURNED TO EXCHANGE THE NON-WIRELESS PROGRAMMER FOR A WIRELESS PROGRAMMER. NO INFORMATION WAS RECEIVED INDICATING PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256007 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090AA

    Patients

    Seq Age Sex Outcome Treatment
    1