BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791149 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01578
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 3, 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. 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND. THE TEMPORARY PACING CABLE WAS ANALYZED AND WAS FOUND TO BE OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THRESHOLD MEASUREMENT ON THE EXTERNAL PULSE GENERATOR (EPG) WAS NOT ACCURATE. THE DEVICE WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THRESHOLD MEASUREMENT ON THE EXTERNAL PULSE GENERATOR (EPG) WAS NOT ACCURATE. THE DEVICE WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE EPG DID NOT HAVE GOOD PACING. IT WAS CONFIRMED THAT THE CABLE WAS NOT GOOD AND THE DEVICE WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other