BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA SR

    MDR report key: 1964243 · Received January 19, 2011

    Report

    Report Number
    2647346-2011-00028
    Event Type
    Death
    Date Received
    January 19, 2011
    Date of Event
    March 5, 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.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED 5 WEEKS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED 5 WEEKS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH PHYSICIAN REPORTED PATIENT LAST SEEN IN CLINIC A MONTH PRIOR TO DEATH. IT WAS UNKNOWN TO PHYSICIAN WHAT CAUSE OF DEATH WAS. PATIENT HAD BEEN HOSPITALIZED THREE MONTHS PRIOR TO DEATH WITH CHEST PAIN AND ABDOMINAL PAIN. FOLLOW UP WITH THE PHYSICIAN REPORTED "THERE WAS NO PROBLEM WITH THE PACEMAKER OR LEAD SYSTEM. THE PATIENT HAD END-STAGE CARDIOMYOPATHY."

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED 5 WEEKS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH PHYSICIAN REPORTED PATIENT LAST SEEN IN CLINIC A MONTH PRIOR TO DEATH. IT WAS UNKNOWN TO PHYSICIAN WHAT CAUSE OF DEATH WAS OR IF WAS RELATED TO DEVICE OR LEAD SYSTEM. PATIENT HAD BEEN HOSPITALIZED THREE MONTHS PRIOR TO DEATH WITH CHEST PAIN AND ABDOMINAL PAIN. PATIENT HAD NOT BEEN PACEMAKER DEPENDENT.

    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 93 YR Death