BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 24780736 · Received April 3, 2026

    Report

    Report Number
    2182207-2026-00891
    Event Type
    Injury
    Date Received
    April 3, 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. B3: PLEASE NOTE THE DATE OF EVENT(S) IS 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 47-YEAR-OLD MAN WITH A 13-YEAR HISTORY OF PD PRESENTED TO AN EMERGENCY DEPARTMENT WITH SPEECH DISTURBANCE, DROOLING, AND WORSENING PARKINSONISM. THREE YEARS EARLIER, HE HAD UNDERGONE BILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN-DBS) FOR REFRACTORY TREMOR. POST-DBS IMPLANTATION, HIS MOTOR SYMPTOMS WERE WELL CONTROLLED. ON EXAMINATION, HE WAS FEBRILE (38 C) AND EXHIBITED DYSARTHRIA, SEVERE RIGIDITY, BRADYKINESIA, HYPOKINESIA, AND TREMOR. HE WAS AWAKE AND ALERT (GLASGOW COMA SCALE [GCS] SCORE: 15/15). HIS MOVEMENT DISORDER SOCIETY-UNIFIED PARKINSON¿S DISEASE RATING SCALE (MDS-UPDRS III) SCORE WAS 72. DESPITE ESCALATING LEVODOPA TO 2500 MG/DAY, HIS CONDITION DETERIORATED. LABORATORY STUDIES REVEALED MARKEDLY ELEVATED CPK LEVELS (5287 IU/L) WITHOUT MYOGLOBINURIA OR EVIDENCE OF INFECTION. BRAIN IMAGING CONFIRMED CORRECT ELECTRODE PLACEMENT, BUT DEVICE INTERROGATION DEMONSTRATED IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY DEPLETION. MANAGEMENT INCLUDED INTRAVENOUS HYDRATION, RE-INITIATION OF ORAL LEVODOPA, AND URGENT STN-DBS BATTERY REPLACEMENT. WITHIN DAYS, HIS MDS-UPDRS III SCORE IMPROVED TO 17, AND SERUM CPK NORMALIZED OVER FOUR DAYS. AT TWO-WEEK FOLLOW-UP, HE HAD ACHIEVED FULL CLINICAL RECOVERY. 2. IT WAS REPORTED THAT A 60-YEAR-OLD MAN WITH A 19-YEAR HISTORY OF PD PRESENTED WITH SUDDEN EXACERBATION OF TREMOR AND ALTERED CONSCIOUSNESS. HE HAD UNDERGONE BILATERAL STN-DBS IN 2008 FOR REFRACTORY TREMOR AND PEAK-DOSE DYSKINESIAS, AND HIS SYMPTOMS REMAINED WELL CONTROLLED. HE SUBSEQUENTLY UNDERWENT ELECTIVE INS REPLACEMENTS THREE AND SEVEN YEARS BEFORE PRESENTATION. ON ARRIVAL, HE WAS FEBRILE (38 C), LETHARGIC (GCS SCORE: 13/15), AND EXHIBITED GENERALIZED RIGIDITY; MENTAL STATUS IMPAIRMENT PRECLUDED MDS-UPDRS III ASSESSMENT. LABORATORY STUDIES SHOWED LEUKOCYTOSIS (WBC: 16,900/MM3) AND ELEVATED CPK (1432 IU/L). SEPSIS WORKUP, INCLUDING CHEST CT, URINALYSIS, AND CSF ANALYSIS, AND COVID-19 PCR WERE NEGATIVE. BRAIN CT CONFIRMED CORRECT LEAD POSITIONING, BUT DEVICE INTERROGATION REVEALED INS BATTERY DEPLETION. HE RECEIVED INTRAVENOUS HYDRATION AND UNDERWENT URGENT INS REPLACEMENT. POSTOPERATIVELY, LEVODOPA WAS RESUMED, AND DANTROLENE PLUS BROMOCRIPTINE WAS ADMINISTERED VIA NASOGASTRIC TUBE. CONSCIOUSNESS PARTIALLY RETURNED BY POSTOPERATIVE DAY 3, WITH MOTOR FUNCTION IMPROVING TO AN MDS-UPDRS III SCORE OF 12 OVER THE FOLLOWING DAYS. SERUM CPK NORMALIZED (194 IU/ L), AND AT TWO-WEEK FOLLOW-UP HE HAD REGAINED FULL MOTOR FUNCTION. 3. IT WAS REPORTED THAT A 68-YEAR-OLD MAN WITH AN 18-YEAR HISTORY OF PD PRESENTED WITH LOCALIZED ERYTHEMA AND PURULENT DISCHARGE AT THE SITE OF INS. HE REPORTED MILD WORSENING OF TREMOR, RIGIDITY, AND HYPOKINESIA. HE HAD UNDERGONE BILATERAL STN-DBS IMPLANTATION IN 2018 FOR MEDICATION-REFRACTORY TREMOR WITH SUCCESSFUL CONTROL OF SYMPTOMS. ON EXAMINATION, HE WAS AFEBRILE AND ALERT (GCS SCORE: 15/15). HIS MOTOR MDS-UPDRS III SCORE WAS 18. THE INS WAS ERODING THROUGH THE SKIN, WITH FLUID COLLECTION AROUND IT. DEVICE INTERROGATION REVEALED BATTERY DEPLETION. LABORATORY STUDIES SHOWED A RISE IN SERUM CPK FROM 444 TO 758 IU/L, WITHOUT LEUKOCYTOSIS OR ELEVATED SYSTEMIC INFLAMMATORY MARKERS. HE UNDERWENT SURGICAL DEBRIDEMENT OF THE BATTERY SITE WOUND AND RECEIVED INTRAVENOUS ANTIBIOTICS TO PREVENT INFECTION. IPG REPLACEMENT WAS THEN PERFORMED, LEADING TO COMPLETE RESOLUTION OF SYMPTOMS. AT FOLLOW-UP, HIS MOTOR MDS-UPDRS III SCORE HAD IMPROVED TO 10. 4. IT WAS REPORTED THAT A 60-YEAR-OLD MAN WITH A 24-YEAR HISTORY OF PD PRESENTED TO AN EMERGENCY DEPARTMENT WITH AGGRAVATION OF TREMOR, BRADYKINESIA, HYPOKINESIA, AND RIGIDITY OF THE LIMBS, WHICH HAD STARTED THREE DAYS BEFORE ADMISSION. THE PATIENT INCREASED THE LEVODOPA DOSE TO TWELVE 250 MG TABLETS DAILY WITHOUT CLINICAL IMPROVEMENT. HE HAD UNDERGONE BILATERAL STN-DBS IN 2012, WITH BATTERY REPLACEMENT IN 2016. POSTOPERATIVELY, HE ACHIEVED SATISFACTORY SYMPTOM CONTROL ON A REGIMEN OF LEVODOPA, PRAMIPEXOLE, AND AMANTADINE. ON EXAMINATION, HE WAS AFEBRILE, ALERT, AND ORIENTED (GCS SCORE: 15/15). HIS MOTOR MDS-UPDRS III SCORE WAS 32. LABORATORY STUDIES REVEALED ELEVATED CPK LEVELS (2729 IU/L), WITH A NORMAL LEUKOCYTE COUNT, ELECTROLYTES, AND URINALYSIS. DEVICE INTERROGATION CONFIRMED INS BATTERY DEPLETION, LEADING TO A DIAGNOSIS OF PHS. HE WAS MANAGED WITH INTRAVENOUS HYDRATION, REINSTITUTION OF LEVODOPA, AND DANTROLENE, FOLLOWED BY URGENT IPG REPLACEMENT. WITHIN 48 HOURS POST-REPLACEMENT, HIS MOTOR SYMPTOMS IMPROVED MARKEDLY (MDS-UPDRS III: 14), AND CPK LEVELS STEADILY DECLINED TOWARD NORMAL. 5. IT WAS REPORTED THAT A 45-YEAR-OLD MAN WITH AN 11-YEAR HISTORY OF PD PRESENTED WITH A TWO-WEEK HISTORY OF PROGRESSIVE MOTOR DECLINE CULMINATING IN AN INABILITY TO PERFORM ACTIVITIES OF DAILY LIVING. HE HAD UNDERGONE BILATERAL STN-DBS IN 2016 FOR MEDICATION-REFRACTORY TREMOR, AND WAS MAINTAINED ON LEVODOPA WITH EXCELLENT SYMPTOM CONTROL. ON EXAMINATION, HE WAS ALERT (GCS SCORE: 15/15) AND AFEBRILE BUT EXHIBITED DYSARTHRIA, GENERALIZED TREMOR, RIGIDITY IN ALL FOUR LIMBS, AND WAS UNABLE TO WALK WITHOUT ASSISTANCE. HIS MOTOR MDS-UPDRS III SCORE WAS 36. INITIAL LABORATORY EVALUATION DEMONSTRATED LEUKOCYTOSIS (WBC: 14 ,500/MM3) AND CPK LEVELS OF 672 IU/L, WHICH ROSE TO 2368 IU/L DESPITE A NEGATIVE SEPSIS WORKUP AND UNREMARKABLE BRAIN CT. DEVICE INTERROGATION CONFIRMED INS BATTERY DEPLETION. HE RECEIVED INTRAVENOUS HYDRATION, REINSTITUTION OF LEVODOPA, AND BROMOCRIPTINE, FOLLOWED BY URGENT IPG BATTERY REPLACEMENT. POSTOPERATIVELY, HIS MDS-UPDRS III SCORE IMPROVED TO 18 AND CPK LEVELS WERE NORMALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837809 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION 37601 UNKNOWN

    Patients

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