BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2953557 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00334
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    December 6, 2012
    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: THE DEVICE FAILED ALL UPLINK AMPLITUDE TESTS DUE TO THE CABLE BEING OUT OF ELECTRICAL SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER PEN CAN NOT BE USED. TRIED SWAPPING PENS BUT STILL DID NOT WORK. IT WAS ALSO REPORTED THE SCREEN IS CRACKED. THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE RETURNED FOR REPAIR. BOTH PRODUCTS WERE ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55936 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER, 2290 ANALYZER