BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 2952535 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00192
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTE
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BIOMEDICAL ENGINEER HEARD "RATTLING" INSIDE THE EXTERNAL PULSE GENERATOR (EPG). THE EPG WAS OPENED AND THE CALLER FOUND THAT A SCREW WAS LOOSE AND "FLOATING" WITHIN THE EPG. THE CALLER ATTACHED THE SCREW AND TESTED THE EPG. TECHNICAL SERVICES WORKED WITH THE CALLER AND THE DEVICE TESTED WITHIN SPECIFICATIONS. THE EPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56213 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE RICE CREEK MFG 5388

    Patients

    Seq Age Sex Outcome Treatment
    1