BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 21009266 · Received December 23, 2024

    Report

    Report Number
    2182207-2024-04970
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    November 22, 2024
    Report Date
    December 23, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    PJS
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 3387 LOT# UNKNOWN PRODUCT TYPE LEAD PRODUCT ID 3387 LOT# UNKNOWN PRODUCT TYPE LEAD PRODUCT ID 3387 LOT# UNKNOWN PRODUCT TYPE LEAD PRODUCT ID 3387 LOT# UNKNOWN PRODUCT TYPE LEAD PRODUCT ID 3387 LOT# UNKNOWN PRODUCT TYPE LEAD PRODUCT ID 37602 SERIAL# UNKNOWN PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3387 LOT# UNKNOWN PRODUCT TYPE LEAD PRODUCT ID 3387 LOT# UNKNOWN PRODUCT TYPE LEAD PRODUCT ID 3387 LOT# UNKNOWN PRODUCT TYPE LEAD PRODUCT ID 3387 LOT# UNKNOWN PRODUCT TYPE LEAD PRODUCT ID 3387 LOT# UNKNOWN PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 37602, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN, PERSSON, R. S., BLOMSTEDT, Y., FYTAGORIDIS, A., HARIZ, M. BLOMSTEDT, P. AWAKE VERSUS ASLEEP DEEP BRAIN STIMULATION TARGETING THE CAUDAL ZONA INCERTA FOR ESSENTIAL TREMOR. NPJ PARK.¿S DIS. 10, 226 (2024). DOI: 10.1038/S41531-024-00833-9. A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B.5. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. 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

    PERSSON, R. S., BLOMSTEDT, Y., FYTAGORIDIS, A., HARIZ, M. BLOMSTEDT, P. AWAKE VERSUS ASLEEP DEEP BRAIN STIMULATION TARGETING THE CAUDAL ZONA INCERTA FOR ESSENTIAL TREMOR. NPJ PARK.¿S DIS. 10, 226 (2024). DOI: 10.1038/S41531-024-00833-9. SUMMARY: TO COMPARE AWAKE AND ASLEEP DEEP BRAIN STIMULATION (DBS) SURGERY FOR ESSENTIAL TREMOR (ET), WE CONDUCTED THIS RETROSPECTIVE COHORT STUDY OF PATIENTS CONSECUTIVELY OPERATED WITH DBS TARGETING THE CAUDAL ZONA INCERTA (CZI). 37 UNDERWENT SURGERY AWAKE AND 55 ASLEEP. TREMOR BEFORE SURGERY AND ON/OFF STIMULATION ONE YEAR AFTER SURGERY WERE EVALUATED USING THE ESSENTIAL TREMOR RATING SCALE (ETRS). PROCEDURAL TIME, ELECTRODE LOCALIZATION, STIMULATION PARAMETERS AND ADVERSE EVENTS WERE NOTED AND COMPARED. ETRS SCORES WERE SIMILAR AT BASELINE BETWEEN THE GROUPS EXCEPT FOR CONTRALATERAL ARM TREMOR, WHICH WAS SLIGHTLY WORSE IN THE AWAKE GROUP. TOTAL ETRS, CONTRALATERAL ARM TREMOR AND ACTIVITIES OF DAILY LIVING SCORES SHOWED NO SIGNIFICANT DIFFERENCE BETWEEN THE GROUPS ON-STIMULATION AT ONE-YEAR FOLLOW-UP. COMPARED TO THE AWAKE GROUP, THE ASLEEP GROUP HAD SHORTER PROCEDURAL TIME AND LOWER STIMULATION PARAMETERS. THERE WERE NO INTRACRANIAL HAEMORRHAGES NOR SURGERY SITE-INFECTIONS. BOTH GROUPS SHOWED A GOOD IMPROVEMENT OF TREMOR AT ONE-YEAR FOLLOW-UP. IMAGE-GUIDED DBS SURGERY TARGETING THE CZI ENABLES SAFE AND EFFICIENT ASLEEP SURGERY FOR ET. REPORTED EVENTS: 1. IT WAS REPORTED THAT 4 PATIENT'S WHO WERE IMPLANTED WITH DBS ELECTRODES EXPERIENCED INTRAOPERATIVE ELECTRODE REPOSITIONING/EXTRA ELECTRODE. 2. IT WAS REPORTED THAT 1 PATIENT WHO WAS IMPLANTED WITH DBS ELECTRODES EXPERIENCED GAIT DISTURBANCES, DIZZINESS, AND HEADACHE DURING THE FIRST 2 WEEKS OF SURGERY. IMAGING REVEALED SIGNIFICANT PERI-ELECTRODE OEDEMA WITHOUT CONTRAST-ENHANCEMENT AND THE PATIENT HAD NEITHER FEVER NOR INFECTION PARAMETERS. EXTIRPATION OF THE ELECTRODE LED TO FULL RECOVERY AND THE REACTION WAS CONSIDERED TO BE DUE TO THE INFLAMMATORY REACTION AROUND THE DBS ELECTRODE. 3. IT WAS REPORTED THAT 1 PATIENT WHO WAS IMPLANTED WITH DBS ELECTRODES EXPERIENCED A LACUNAR INFARCTION. 4. IT WAS REPORTED THAT 1 PATIENT WHO WAS IMPLANTED WITH DBS ELECTRODES EXPERIENCED SUDDEN MILD HEMIPARESIS THREE DAYS AFTER SURGERY AND CONCURRENT PNEUMONIA. THE WEAKNESS IMPROVED BUT PERSISTED TO SOME DEGREE FIVE MONTHS LATER AND WAS DEEMED BEDUE TO A LACUNAR ISCHEMIC STROKE. 5. IT WAS REPORTED THAT 1 PATIENT WHO WAS IMPLANTED WITH DBS ELECTRODES EXPERIENCED A URINARY TRACT INFECTION. 6. IT WAS REPORTED THAT 1 PATIENT WHO WAS IMPLANTED WITH DBS ELECTRODES EXPERIENCED A PULMONARY EMBOLISM. 7. IT WAS REPORTED THAT 3 PATIENT'S WHO WERE IMPLANTED WITH DBS ELECTRODES EXPERIENCED STRAINING CABLE/MIGRATING IPG NEEDING SURGICAL ADJUSTMENT. 8. IT WAS REPORTED THAT 1 PATIENT WHO WAS IMPLANTED WITH DBS ELECTRODES EXPERIENCED A MYOCARDIAL INFARCTION 1 MONTH POST-OPERATION. 9. IT WAS REPORTED THAT 1 PATIENT WHO WAS IMPLANTED WITH DBS ELECTRODES EXPERIENCED AN IPSILATERAL STROKE. 10. IT WAS REPORTED THAT 1 PATIENT WHO WAS IMPLANTED WITH DBS ELECTRODES EXPERIENCED INCREASED SEIZURE FREQUENCY. 11. IT WAS REPORTED THAT 1 PATIENT WHO WAS IMPLANTED WITH DBS ELECTRODES EXPERIENCED A SUPRAPUBIC CATHETER. PATIENT'S WERE IMPLANTED WITH EITHER THE 3387 OR 3389 ELECTRODE MODELS. THE EXTENSION CABLES AND IMPLANTABLE PULSE GENERATOR MODELS WERE: KINETRA/SOLETRA/ACTIVA SC/PC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2511998 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI PJS MEDTRONIC NEUROMODULATION 3387 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention "SEE H11...."