BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA DR

    MDR report key: 1926011 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02308
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 8, 2010
    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 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. 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) THE DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT A WRENCH WAS STUCK IN THE SETSCREW AND THAT THE ATRIAL GROMMET WAS DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT WAS TRIGGERED AND HIGH IMPEDANCE WAS MEASURED. WHILE CHANGING OUT THE LEAD THE IMPLANTER NOTICED BLOOD IN THE CONNECTOR BLOCK AND THEN HAD PROBLEMS TURNING THE SETSCREW. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE 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. D364DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R