BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA DR

    MDR report key: 1914555 · Received December 3, 2010

    Report

    Report Number
    2647346-2010-00782
    Event Type
    Death
    Date Received
    December 3, 2010
    Date of Event
    April 8, 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
    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.

    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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED 8 MONTHS AFTER DEVICE IMPLANT. FOLLOW UP REVEALED DEATH CERTIFICATE NOTED CAUSE OF DEATH WAS ACUTE RESPIRATORY FAILURE DUE TO PNEUMONIA DUE TO CONGESTIVE HEART FAILURE DUE TO ISCHEMIC CARDIOMYOPATHY. NO AUTOPSY WAS DONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED 8 MONTHS 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 DR ASKU NVZ MEDTRONIC MED REL, INC. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death LEAD/COMP IMPLANTABLE PACING LEAD| LEAD/PAC IMPLANTABLE PACING LEAD| LEAD/COMP IMPLANTABLE PACING LEAD| LEAD/PAC IMPLANTABLE PACING LEAD| LEAD/PAC IMPLANTABLE PACING LEAD| LEAD/COMP IMPLANTABLE PACING LEAD