BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2953711 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00341
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    December 4, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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 CONFIRMED THE REPORTED EVENT, THE PRINTER DRAWER WAS DAMAGED. IT WAS ALSO NOTED THAT THE MEDIA BAY DOOR LATCH WAS DAMAGED, THE SYSTEM FAN WAS NOISY, AND FURTHER INVESTIGATION FOUND THAT THE EMERGENCY PACING BUTTON WAS NOT FUNCTIONING, AFTER THE CONNECTION OF THE FLEX TAPE TO THE PRINTED CIRCUIT BOARD WAS RESEATED, THE BUTTON FUNCTIONED NORMALLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD A DAMAGED PRINTER. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO INDICATION GIVEN THAT THERE WAS ANY PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56382 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090AA4

    Patients

    Seq Age Sex Outcome Treatment
    1 2290 PACING SYSTEM ANALYZER