BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3051529 · Received April 10, 2013

    Report

    Report Number
    2182208-2013-01064
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    November 27, 2012
    Report Date
    February 26, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    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. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE UPLINK AMPLITUDE OUT OF SPECIFICATION; RF (RADIO FREQUENCY) HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION. ANALYSIS ALSO FOUND THE RF HEAD LABEL IS DELAMINATED. PRODUCT ID: 209031 PROGRAMMER; PRODUCT ID 229047 ANALYZER. (B)(4).

    Description of Event or Problem · 1

    THE RF (RADIO FREQUENCY) HEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO INDICATION WAS GIVEN AS TO PATIENT INVOLVEMENT OR IMPACT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149770 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1