BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA DR

    MDR report key: 2123896 · Received June 14, 2011

    Report

    Report Number
    6000094-2011-00727
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 2, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE SEALING RINGS IN THE CONNECTOR OF THE DEVICE. THERE WAS HIGH IMPEDANCE AND THERE WAS BLOOD IN THE HEADER. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D364DRM ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R