BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2811904 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01854
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 14, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S70
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY: (B)(4) - ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EXTERNAL PULSE GENERATOR (EPG) FAILED TO PACE WHEN THE PATIENT WAS MOVED. AFTER THAT, THE EPG WAS USED CONTINUOUSLY, WITH NORMAL OPERATION. IT WAS FURTHER REPORTED BY THE PHYSICIAN THAT AN ISSUE WITH THE POSITION OF THE PACING LEAD WAS SUSPECTED. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 Other