BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3046123 · Received April 10, 2013

    Report

    Report Number
    2183613-2013-00376
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE SUSPECT MEDICAL DEVICE WAS INADVERTENTLY REPORTED FOR THIS COMPLAINT UNDER MANUFACTURING REPORT NUMBER 2183613-2013-00376 AND SUBMITTED 10APRIL2013, AND AS A RESULT THIS REPORT IS BEING REDACTED. THE INFORMATION WAS SUBMITTED UNDER MANUFACTURING REPORT NUMBER 2183613-2013-00300 ON 10APRIL2013 AND A SUPPLEMENTAL REPORT WAS SENT 10JUNE2013.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS NOT CAPTURING. TESTING WAS DONE AND THE BIOMEDICAL ENGINEER WAS NOT ABLE TO REPRODUCE THE ISSUE. THERE WAS NO REFRACTORY RESULT SHOWN WHILE TESTING. THE EPG WILL BE RETURNED FOR ADDITIONAL TESTING AND CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS NOT CAPTURING. TESTING WAS DONE AND THE BIOMEDICAL ENGINEER WAS NOT ABLE TO REPRODUCE THE ISSUE. THERE WAS NO REFRACTORY RESULT SHOWN WHILE TESTING. THE EPG WILL BE RETURNED FOR ADDITIONAL TESTING AND CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150339 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE DTE MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1