BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSULTA

    MDR report key: 1911849 · Received December 1, 2010

    Report

    Report Number
    2647346-2010-00761
    Event Type
    Death
    Date Received
    December 1, 2010
    Date of Event
    September 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ASKU

    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): PROXIMAL SEGMENT OF THE LEAD RETURNED AND ANALYZED. VISUAL ANALYSIS PERFORMED ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED ONE MONTH AND SEVENTEEN DAYS POST IMPLANT OF A DEVICE AND TWO LEADS. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH CLINIC REPORTED SHE DOES NOT THINK THE PATIENT DEATH HAD ANYTHING TO DO WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED ONE MONTH AND SEVENTEEN DAYS POST IMPLANT OF A DEVICE AND TWO LEADS. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death