BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 2952286 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00146
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 22, 2012
    Report Date
    November 22, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTE
    PMA / PMN Number
    K971474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS RECEIVED FROM THE CUSTOMER WITH NO INFORMATION. THE ENGINEER TESTED THE EPG AND FOUND MAIN BOARD MALFUNCTION. THE STATUS OF THE EPG IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56327 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE RICE CREEK MFG 5318D4

    Patients

    Seq Age Sex Outcome Treatment
    1