BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ C SERIES SR

    MDR report key: 2812451 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02535
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    January 2, 2013
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE ANALYSIS REVIEW FOUND NO ANOMALIES.

    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION THE DEVICE SHOWED AN ERROR. A REVIEW OF THE DEVICE PERFORMANCE DATA FOUND THAT A BIT FLIP OCCURRED AND A MANUAL GUIDED RESET (MGR) WAS NEEDED. THE MGR WILL BE SCHEDULED AND 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 DA+ C SERIES SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. C10A4U

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention