BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ C SERIES SR

    MDR report key: 2811411 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02385
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 7, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION. THE DEVICE WAS REMOVED AND A POCKET DEBRIDEMENT TOOK PLACE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WAS PLACED BACK OR REMOVED PERMANENTLY. NO FURTHER 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. C10A3

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R