BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151860 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01230
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 18, 2013
    Report Date
    May 10, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: PRODUCT ID 2067L RADIO FREQUENCY PROGRAMMER HEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PROGRAMMER WAS RETURNED AND ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE DEVICE WOULD NOT POWER UP. ANALYSIS DID FIND THAT THE PROGRAMMER WAS RETURNED WITH NO KEYBOARD, AND THAT BOTH HINGES WERE BROKEN, AND THAT THE PROGRAMMER HAD A NOISY SYSTEM FAN, THAT THE CASE WAS MISSING ITS BOTTOM "FEET" AS WELL AS HAVING MISSING AND LOOSE HINGE PLATE SCREWS. PRODUCT ID 2067L RADIO FREQUENCY PROGRAMMER HEAD. (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 THAT THE PROGRAMMER WOULD NOT TURN ON. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT TURN ON. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. IT WAS FURTHER NOTED ON AN EARLIER DOCUMENT THAT THE PROGRAMMER WAS UNABLE TO INTERROGATE. THE RADIO FREQUENCY (RF) PROGRAMMER HEAD WAS RETURNED ALONG WITH THE PROGRAMMER AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252628 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1