BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 2813646 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01871
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 27, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    DTE
    PMA / PMN Number
    K971474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. EVALUATION SUMMARY: NO ANOMALIES FOUND. IT IS NOTED THAT THE BATTERY RETURNED WITH THE DEVICE WAS RUN DOWN; ONCE THE BATTERY WAS REPLACED, THE DEVICE TESTED OK.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENGINEER TESTED THE EXTERNAL PULSE GENERATOR (EPG) AND DISCOVERED THAT THE DISPLAY SCREEN DID NOT SHOW. THE EPG WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENGINEER TESTED THE EXTERNAL PULSE GENERATOR (EPG) AND DISCOVERED THAT THE DISPLAY SCREEN DID NOT SHOW. THE EPG WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE MEDTRONIC MILACA, INC. 5318

    Patients

    Seq Age Sex Outcome Treatment
    1 Other