BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA SR

    MDR report key: 2791665 · Received October 15, 2012

    Report

    Report Number
    2647346-2012-01729
    Event Type
    Death
    Date Received
    October 15, 2012
    Date of Event
    October 18, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM. (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY ONE MONTH POST IMPLANT OF THE IPG APPROXIMATELY TWO YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death