BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152216 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01163
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    March 19, 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 THAT THE HEAD CABLE WAS DAMAGED NEAR THE BASE OF THE HEAD AND THE INSULATION WAS CUT. THE DEVICE WAS PLUGGED INTO THE PROGRAMMER AND MOVED THE CABLE NEAR THE BASE AND THE PROGRAMMER SHUT OFF. CONCOMITANT PRODUCT: PRODUCT ID 2090 PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS POWERED UP, BUT THE SCREEN WENT BLACK AND THE PROGRAMMER SHUT DOWN AND WOULD NOT POWER BACK UP AGAIN. THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE RETURNED FOR SERVICE, ANALYZED AND TESTED OUT OF SPECIFICATION. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252987 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1