BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 17426723 · Received July 31, 2023

    Report

    Report Number
    3004209178-2023-13511
    Event Type
    Death
    Date Received
    July 31, 2023
    Date of Event
    February 24, 2022
    Report Date
    July 31, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    PJS
    UDI-DI
    00613994761057
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2023 AND STATED THAT THE DEATH WAS RELATED TO THE DBS IMPLANT. THE CALLER STATED THAT THE PATIENT LOST GROUND AFTER THE IMPLANTS WERE REMOVED. THE CALLER STATED THAT THE MONDAY PRIOR TO THE PATIENTS DEATH , THE PATIENTS BLOOD PRESSURE GOT REALLY HIGH AND WAS TAKEN TO THE EMERGENCY ROOM BY AMBULANCE DUE THE PATIENT NOT BEING ABLE TO STAND UP FROM LACK OF STRENGTH. THE CALLER STATED THEY MADE THE PATIENT A DO NOT RESUSCITATE ON THE SECOND DAY (WHILE IN THE HOSPITAL) , BECAUSE THE PATIENT WAS DECLINING AND THEY WERE EVERYTHING THEY COULD DO FOR HER. THE CALLER STATED THAT WHEN THE PATIENT WENT INTO THE HEALTHCARE PROVIDER (HCP) OFFICE IN JULY THERE WAS A "BIG HOLE IN HER HEAD" WHERE THE INFECTION WAS . AND THAT THE PATIENT NEVER RECOVERED FROM HAVING THE IMPLANTABLE NEUROSTIMULATOR EXPLANTED. FOR RELEVANT MEDICAL HISTORY THE PATIENT HAD A PACEMAKER IMPLANTED IN SEPTEMBER. OTHER RELEVANT MEDICAL HISTORY: THE PATIENT WAS ON METOPROLOL AND XARELTO DURING THE TIME OF HER DEATH. ON THE PATIENTS DEATH CERTIFICATE ACUTE HYPOXIC RESPIRATORY FAILURE, ISCHEMIC STROKES AND ACUTE HYPERCAPNIC FAILURE IS LISTED AS PATIENTS CAUSE OF DEATH. REFER TO MANUFACTURER'S REPORT 3004209178-2023-13508 FOR DETAILS PERTAINING TO THE REPORTABLE RELATED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645591 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI PJS MEDTRONIC PUERTO RICO OPERATIONS CO. 37602 00613994761057

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Hospitalization| D