BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA DR

    MDR report key: 1924435 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02260
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 26, 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 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 EVALUATED AND NO ANOMALIES WERE FOUND.

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ALERT TONE WAS ACTIVATED FOR SEVERAL HOURS BUT NO ALERT CRITERIA WERE MET AND NO ALERT EVENTS WERE SAVED. NO MAGNET WAS IN THE DEVICE VICINITY. TONE WAS TURNED OFF WHEN ALL ALERT CRITERIA WERE DISABLED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ALERT TONE WAS ACTIVATED FOR SEVERAL HOURS BUT NO ALERT CRITERA WERE MET AND NO ALERT EVENTS WERE SAVED. NO MAGNET WAS IN THE DEVICE VICINITY. THE TONE WAS TURNED OFF WHEN ALL ALERT CRITERIAS WERE PROGRAMMED OFF. 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. D364DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R