BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA SR

    MDR report key: 1961423 · Received January 14, 2011

    Report

    Report Number
    2647346-2011-00021
    Event Type
    Death
    Date Received
    January 14, 2011
    Date of Event
    November 6, 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): 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED APPROXIMATELY 9 WEEKS AFTER DEVICE IMPLANT. FOLLOW UP WITH CLINIC REPORTED PATIENT WAS PACEMAKER DEPENDENT. LAST DEVICE CHECK WAS THE DAY PRIOR TO DEATH AND NOTED IMPEDANCES WERE OKAY. THE CAUSE OF DEATH WAS REPORTED TO BE CONGESTIVE HEART FAILURE AND THERE IS NO ALLEGATION OF ANY DEVICE SYSTEM ISSUES OR PERFORMANCE CONCERNS.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED APPROXIMATELY 9 WEEKS AFTER DEVICE 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 86 YR Death