BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 24772621 · Received April 2, 2026

    Report

    Report Number
    2182207-2026-00890
    Event Type
    Death
    Date Received
    April 2, 2026
    Date of Event
    September 29, 2025
    Report Date
    April 2, 2026
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: HABIBI SAH, EISSAZADE N, LOTFI T, PARVARESH-RIZI M, SHAHIDI G, ROHANI M. PARKINSONISM-HYPERPYREXIA SYNDROME FOLLOWING DEEP BRAIN STIMULATION BATTERY DEPLETION DURING THE COVID-19 PANDEMIC: A CASE SERIES AND REVIEW OF THE LITERATURE. MOV DISORD CLIN PRACT. 2026 JAN;13(1):248-255. DOI: 10.1002/MDC3.70320. A2: PLEASE SEE B5. A3A: PLEASE SEE B5. B2 , B3: PLEASE NOTE THAT BOTH THE DATE OF EVENT AND DATE OF DEATH ARE BASED ON THE ARTICLE'S ONLINE PUBLICATION DATE AS NO FURTHER DETAILS WERE PROVIDED IN THE ARTICLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    REPORTED EVENTS: 1. IT WAS REPORTED THAT A 60-YEAR-OLD MAN WITH A 20-YEAR HISTORY OF PD PRESENTED TO THE EMERGENCY DEPARTMENT WITH TREMOR, DYSPHAGIA, AND SPEECH DISTURBANCE. HE HAD UNDERGONE BILATERAL STN-DBS IMPLANTATION IN 2006 FOR TREMOR AND HYPOKINESIA; THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY HAD BEEN REPLACED IN 2009, 2014, AND 2017. ON EXAMINATION, HE WAS AFEBRILE AND FULLY CONSCIOUS (GCS SCORE: 15/15) BUT EXHIBITED MONOTONE HYPOPHONIC DYSARTHRIA, TREMOR, RIGIDITY IN ALL LIMBS, BRADYKINESIA, AND HYPOKINESIA. HIS MOTOR MDS-UPDRS III SCORE WAS 42. LABORATORY STUDIES DEMONSTRATED MARKEDLY ELEVATED CPK (4625 IU/L), LEUKOCYTOSIS (WBC: 13 ,400/MM3), ELEVATED ESR AND CRP, AND RENAL FUNCTION IMPAIRMENT (CR:2.5 MG/DL; BUN: 66 MG/DL). COVID-19 PCR AND SEPSIS WORKUP, INCLUDING CHEST IMAGING, URINALYSIS, AND CSF ANALYSIS, WERE NEGATIVE. BRAIN IMAGING CONFIRMED CORRECT LEAD PLACEMENT, BUT DEVICE INTERROGATION REVEALED INS BATTERY DEPLETION. INTRAVENOUS HYDRATION AND LEVODOPA WERE INITIATED; HOWEVER, HIS CONDITION RAPIDLY DETERIORATED, WITH PROGRESSIVE DECLINE IN CONSCIOUSNESS. PLANNED IPG REPLACEMENT WAS DEFERRED DUE TO HEMODYNAMIC INSTABILITY, AS BOTH THE SURGICAL AND ANESTHESIOLOGY CONS ULTANTS DEEMED EVEN LOCAL ANESTHESIA TOO HIGH-RISK AT THAT TIME. APPROXIMATELY 20 HOURS AFTER ADMISSION, HE SUFFERED A CARDIAC ARREST AND COULD NOT BE RESUSCITATED. 2. IT WAS REPORTED THAT A 75-YEAR-OLD WOMAN WITH A 25-YEAR HISTORY OF PD PRESENTED WITH WORSENING TREMOR, RIGIDITY, FEVER, AND DIAPHORESIS THAT BEGAN 5 DAYS EARLIER. SHE HAD UNDERGONE BILATERAL STN-DBS IMPLANTATION 7 YEARS EARLIER FOR SEVERE TREMOR, AND HER INS WAS REPLACED 4 YEARS AGO. ON ADMISSION, SHE WAS ALERT (GCS SCORE: 15/15) BUT FEBRILE (38 C) AND EXHIBITED SEVERE GENERALIZED TREMOR, LIMB RIGIDITY, DYSARTHRIA, BRADYKINESIA, AND HYPOKINESIA; SHE WAS UNABLE TO WALK WITHOUT ASSISTANCE. HER MOTOR MDS-UPDRS III SCORE WAS 76. LABORATORY STUDIES SHOWED LEUKOCYTOSIS (WBC: 10,600/ MM3) AND ELEVATED CPK (2652 IU/L); SEPSIS WORKUP AND COVID-19 PCR WERE NEGATIVE. DEVICE INTERROGATION CONFIRMED INS BATTERY DEPLETION. SHE WAS TREATED WITH INTRAVENOUS HYDRATION, LEVODOPA, AND ANTIBIOTICS. HOWEVER, HER COURSE WAS COMPLICATED BY PNEUMONIA AND SEVERE ELECTROLYTE DISTURBANCES (HYPOKALEMIA, HYPOMAGNESEMIA, AND HYPOCALCEMIA), LEADING TO HEMODYNAMIC INSTABILITY. AS A RESULT, IPG REPLACEMENT WAS DELAYED, AS THE SURGICAL AND ANESTHESIOLOGY CONSULTANTS JUDGED THAT EVEN LOCAL ANESTHESIA POSED AN UNACCEPTABLE RISK AT THE TIME. DESPITE CONTINUED MANAGEMENT, SHE SUFFERED RESPIRATORY ARREST AND COULD NOT BE RESUSCITATED. PLEASE SEE THE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833167 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION 37601 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death "SEE H11...."