BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC MAXIMO

    MDR report key: 2083711 · Received May 10, 2011

    Report

    Report Number
    2647346-2011-00670
    Event Type
    Death
    Date Received
    May 10, 2011
    Date of Event
    November 5, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY - (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND FOUND TO HAVE NORMAL BATTERY DEPLETION. (B)(4): NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4): NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    AN IMPLANTABLE ICD SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. REVIEW OF MANUFACTURER'S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY 11 MONTHS AFTER DEVICE SYSTEM IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC MAXIMO IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7304 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death COMPETITOR IMPLANTABLE PACING LEAD| COMPETITOR IMPLANTABLE PACING LEAD| COMPETITOR IMPLANTABLE PACING LEAD