BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSULTA

    MDR report key: 1923519 · Received December 14, 2010

    Report

    Report Number
    2647346-2010-00922
    Event Type
    Death
    Date Received
    December 14, 2010
    Date of Event
    November 15, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND; THE PROXIMAL SEGMENT WAS RETURNED FOR ANALYSIS. (B)(4) NO ANOMALIES FOUND: THE PROXIMAL SEGMENT WAS RETURNED FOR ANALYSIS. (B)(4) NO ANOMALIES FOUND: THE PROXIMAL SEGMENT WAS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND; THE PROXIMAL SEGMENT WAS RETURNED FOR ANALYSIS. (B)(4) NO ANOMALIES FOUND: THE PROXIMAL SEGMENT WAS RETURNED FOR ANALYSIS. (B)(4) NO ANOMALIES FOUND: THE PROXIMAL SEGMENT WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED 4 MONTHS AFTER DEVICE WAS IMPLANTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA ASKU NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death