BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2812587 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01922
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 23, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. EVALUATION SUMMARY: (B)(4): NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CONNECTED TO A PATIENT THE EXTERNAL PULSE GENERATOR APPARENTLY SHUT ITSELF OFF. WHEN TURNED BACK ON, IT RESTARTED. WHEN THE GENERATOR WAS CHECKED, NO ABNORMALITY WAS FOUND, AND IT WAS INDICATED THAT IT WOULD BE RETURNED FOR REPAIR. THERE WERE NO PATIENT COMPLICATIONS 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. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention