BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INS 37604 ACTIVA PC+S NEUROSTIMULATOR

    MDR report key: 6279340 · Received January 26, 2017

    Report

    Report Number
    3007566237-2017-00282
    Event Type
    Malfunction
    Date Received
    January 26, 2017
    Date of Event
    November 29, 2016
    Report Date
    January 26, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    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 · 1

    HANRAHAN SJ, NEDRUD JJ, DAVIDSON BS, FARRIS S, GIROUX M, HAUG A, MAHOOR MH, SILVERMAN AK, ZHANG JJ, HEBB AO. LONG-TERM TASK- AND DOP AMINE-DEPENDENT DYNAMICS OF SUBTHALAMIC LOCAL FIELD POTENTIALS IN PARKINSON¿S DISEASE. BRAIN SCIENCES. 2016; 6(57). DOI: 10.3390/BRAINSCI6040057 SUMMARY: SUBTHALAMIC NUCLEUS (STN) LOCAL FIELD POTENTIALS (LFP) ARE NEURAL SIGNALS THAT HAVE BEEN SHOWN TO REVEAL MOTOR AND LANGUAGE BEHAVIOR, AS WELL AS PATHOLOGICAL PARKINSONIAN STATES. WE USE A RESEARCH-GRADE IMPLANTABLE NEUROSTIMULATOR (INS) WITH DATA COLLECTION CAPABILITIES TO RECORD STN-LFP OUTSIDE THE OPERATING ROOM TO DETERMINE THE RELIABILITY OF THE SIGNALS OVER TIME AND ASSESS THEIR DYNAMICS WITH RESPECT TO BEHAVIOR AND DOPAMINERGIC MEDICATION. SEVEN SUBJECTS WERE IMPLANTED WITH THE RECORDING AUGMENTED DEEP BRAIN STIMULATION (DBS) SYSTEM, AND BILATERAL STN-LFP RECORDINGS WERE COLLECTED IN THE CLINIC OVER TWELVE MONTHS. SUBJECTS WERE CUED TO PERFORM VOLUNTARY MOTOR AND LANGUAGE BEHAVIORS IN ON AND OFF MEDICATION STATES. THE STN-LFP RECORDED WITH THE INS DEMONSTRATED BEHAVIOR-MODULATED DESYNCHRONIZATION OF BETA FREQUENCY (13-30HZ) AND SYNCHRONIZATION OF LOW GAMMA FREQUENCY (35-70HZ) OSCILLATIONS. DOPAMINERGIC MEDICATION DID NOT DIMINISH THE RELATIVE BETA FREQUENCY OSCILLATORY SYNCHRONIZATION WITH MOVEMENT. HOWEVER, MOVEMENT-RELATED GAMMA FREQUENCY OSCILLATORY SYNCHRONIZATION WAS ONLY OBSERVED IN THE MEDICATION ON STATE. WE OBSERVED SIGNIFICANT INTER-SUBJECT VARIABILITY, BUT OBSERVED CONSISTENT STN-LFP ACTIVITY ACROSS RECORDING SYSTEMS AND OVER A ONE-YEAR PERIOD FOR EACH SUBJECT. THESE FINDINGS DEMONSTRATE THAT AN INS SYSTEM CAN PROVIDE ROBUST STN-LFP RECORDINGS IN AMBULATORY PATIENTS, ALLOWING FOR THESE SIGNALS TO BE R ECORDED IN SETTINGS THAT BETTER REPRESENT NATURAL ENVIRONMENTS IN WHICH PATIENTS ARE IN A VARIETY OF MEDICATION STATES. REPORTED EVENT: PATIENT 3: ONE (B)(6) FEMALE PATIENT WITH BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE (PD) UNDERWENT DBS RECORDING DURING PERFORMANCE OF BEHAVIORAL TASKS. DURING THE RECORDING, IT WAS FOUND THAT ONE CHANNEL PAIR HAD A SIGNIFICANTLY DIFFERENT PSD (POWER SPECTRAL DENSITY) ESTIMATION COMPARED WITH OTHERS. THIS CHANNEL PAIR HAD IMPEDANCE CONSISTENT WITH AN ELECTRICAL SHORT; IT WAS STATED THAT THIS INCONSISTENT CHANNEL PAIR WAS DUE TO AN ELECTRICAL SHORT. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3389; IMPLANTABLE NEUROSTIMULATOR ACTIVA PC+S MODEL 37604 SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64035 INS 37604 ACTIVA PC+S NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37604 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR