BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 5977700 · Received September 26, 2016

    Report

    Report Number
    3007566237-2016-03369
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    December 21, 2015
    Report Date
    November 15, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR AN OFF LABEL INDICATION.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL INITIATED TO REPORT THE ADDITIONAL INFORMATION RECEIVED. 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

    AKBAR, U., RAIKE, R.S., HACK, N., HESS, C.W., SKINNER, J., MARTINEZ-RAMIREZ, D., DEJESUS, S., OKUN, M.S. RANDOMIZED, BLINDED PILOT TESTING OF NONCONVENTIONAL STIMULATION PATTERNS AND SHAPES IN PARKINSON'S DISEASE AND ESSENTIAL TREMOR: EVIDENCE FOR FURTHER EVALUATING NARROW AND BIPHASIC PULSES. NEUROMODULATION . 2016. 19:4(343-356). DOI: 10.1111/NER.12397. SUMMARY: EVIDENCE SUGGESTS THAT NONCONVENTIONAL PROGRAMMING MAY IMPROVE DEEP BRAIN STIMULATION (DBS) THERAPY FOR MOVEMENT DISORDERS. THE PRIMARY OBJECTIVE WAS TO ASSESS FEASIBILITY OF TESTING THE TOLERABILITY OF SEVERAL NONCONVENTIONAL SETTINGS IN PARKINSON'S DISEASE (PD) AND ESSENTIAL TREMOR (ET) SUBJECTS IN A SINGLE OFFICE VISIT. SECONDARY OBJECTIVES WERE TO EXPLORE FOR POTENTIAL EFFICACY SIGNALS AND TO ASSESS THE ENERGY DEMAND ON THE IMPLANTABLE PULSE-GENERATORS (IPGS). REPORTED EVENTS FOR PATIENTS WITH PARKINSON'S DISEASE - PD8: A PATIENT WITH DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS (STN) FOR PARKINSON'S DISEASE (PD) EXPERIENCED INTOLERABLE DIZZINESS AND BLURRED VISION, AS WELL AS A "STRONG JOLT" WITH THE IRREGULAR FREQUENCY/CLINICAL VOLTAGE SETTING. THEY REPORTED FEELING A TRANSIENT "JOLT" SENSATION ON A NUMBER OF OTHER STIMULATION SETTINGS AS WELL, INCLUDING THE BIPHASIC PULSE WIDTH/CLINICAL VOLTAGE SETTING, THE 50% SHORTER PULSE WIDTH/BASELINE AMPLITUDE SETTING, THE 50% SHORTER PULSE WIDTH/150% BASELINE AMPLITUDE SETTING, AND THE 70% OF BASELINE AMPLITUDE SETTING. PATIENTS WERE IMPLANTED WITH EITHER AN ACTIVA SC, PC, OR RC DEVICE (MODEL 37602/37603, 37601, OR 37612 RESPECTIVELY). ALL PATIENTS WERE IMPLANTED WITH MODEL 3387 LEADS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR VIA A MANUFACTURER REPRESENTATIVE ADDED THAT THE STRONGEST JOLT WAS FELT WITH BIPHASIC PULSE WIDTH/CLINICAL VOLTAGE SETTING AND THE 50% SHORTER PULSE WIDTH/150% BASELINE AMPLITUDE SETTING, AND WAS TRANSIENT EXCEPT THE IRREGULAR FREQUENCY/CLINICAL VOLTAGE SETTING ALSO PRECIPITATED DIZZINESS AND BLURRED VISION. THE IRREGULAR FREQUENCY/CLINICAL VOLTAGE SETTING COULD NOT BE TESTED DUE TO INTOLERABLE SIDE EFFECTS. IT WAS NOTED THAT IN ALL CASES THE SIDE EFFECTS WERE TEMPORARY, LASTING SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628945 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR