BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2865078 · Received December 10, 2012

    Report

    Report Number
    2182208-2012-04072
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 26, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED FUNCTIONAL TESTING. THE CABLE WAS REPLACED AS A PREVENTATIVE. IT WAS ALSO NOTED THAT THE LABEL WAS DELAMINATED. PRODUCT ID 2090 PROGRAMMER; PRODUCT ID (B)(4) ANALYZER

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: (B)(4) SOFTWARE ANALYZER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHAT WAS INITIALLY BELIEVED TO BE A PROGRAMMER ISSUE (WOULD NOT POWER UP) WAS SUBSEQUENTLY FOUND TO BE AN ISSUE WITH THE RADIO FREQUENCY (RF) PROGRAMMER HEAD. WHEN THE HEAD WAS CHANGED TO A DIFFERENT PROGRAMMER, THAT PROGRAMMER ALSO FAILED TO POWER UP, BUT WHEN A DIFFERENT HEAD WAS USED, THAT PROGRAMMER POWERED UP CORRECTLY. THE HEAD IS TO BE RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE RADIO FREQUENCY PROGRAMMER HEAD HAD BEEN RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 (B)(4) PROGRAMMER