BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 2122463 · Received June 13, 2011

    Report

    Report Number
    6000094-2011-00699
    Event Type
    Injury
    Date Received
    June 13, 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 Location
    CA
    Reporter Occupation
    OTHER

    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 AND ANALYZED. THE DEVICE EXPERIENCED A "SERIOUS ICD ERROR" DURING FUNCTIONAL TEST PROGRAMMING. THE DEVICE CAN NO LONGER BE INTERROGATED OR COMMUNICATED WITH; THEREFORE, ANALYSIS IS INCOMPLETE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR DISPOSAL, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC SENTRY IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. 7298 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD