BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA SR

    MDR report key: 1971233 · Received January 26, 2011

    Report

    Report Number
    2647346-2011-00045
    Event Type
    Death
    Date Received
    January 26, 2011
    Date of Event
    August 25, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. (B)(4). THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ONLY VISUAL ANALYSIS WAS PERFORMED. NO ANOMALIES WERE FOUND.

    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). THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ONLY VISUAL ANALYSIS WAS PERFORMED. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    THE PATIENT DIED APPROXIMATELY TWO MONTHS FROM PACEMAKER AND LEAD IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death