BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2953169 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00283
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 19, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND EVALUATED. ANALYSIS FOUND NO ANOMALIES. THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANALYZER FAILED TO CAPTURE THE LEAD DURING THE IMPLANT PROCEDURE. THE SURGERY WAS "SIGNIFICANTLY" LENGTHENED DUE TO THE ANALYZER PROBLEM. THE ANALYZER WAS RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56971 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 229047

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R