BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA SR

    MDR report key: 2812800 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02612
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 25, 2012
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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

    PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION; HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. A POWER ON RESET (POR) OCCURRED WITH THE SAME TIMESTAMP AS THE IMPLANT DATE. THE DEVICE APPEARS TO BE FUNCTIONING NORMALLY AFTER THE POR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO BATTERY VOLTAGE WAS GIVEN AND A SAVE-TO-DISK COULD NOT BE COMPLETED FOR THE DEVICE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other