BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3050947 · Received April 10, 2013

    Report

    Report Number
    2182208-2013-01040
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE UPLINK AMPLITUDE WAS OUT OF SPECIFICATION; RF (RADIO FREQUENCY) HEAD CABLE OUT OF ELECTRICAL SPECIFICATION. THE LABEL ALSO NEEDED TO BE REPLACED. (B)(4).

    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 IS OUT OF SPECIFICATION; RF (RADIO FREQUENCY) HEAD CABLE OUT OF ELECTRICAL SPECIFICATION. (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 PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    THE RF (RADIO FREQUENCY) HEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149766 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1