BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 5977898 · Received September 26, 2016

    Report

    Report Number
    3007566237-2016-03371
    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

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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 ESSENTIAL TREMOR- 1. ET1: A PATIENT WITH DBS OF THE VENTRAL INTERMEDIATE NUCLEUS OF THE THALAMUS (VIM) FOR ESSENTIAL TREMOR (ET) EXPERIENCED VARIOUS SIDE EFFECTS DURING PROGRAMMING TESTING: THEY EXPERIENCED A MILD JOLT IN THE HAND WITH THE BIPHASIC PULSE WIDTH/CLINICAL VOLTAGE SETTING; TRANSIENT FULL BODY TREMOR WITH THE BIPHASIC PULSE WIDTH/70% OF BASELINE AMPLITUDE SETTING; AND A TRANSIENT JOLT IN THE FINGERTIPS WITH THE 50% SHORTER PULSE WIDTH/150% BASELINE AMPLITUDE SETTING. IT WAS NOTED THAT FOR THIS STUDY AN ACTIVA SC OR PC DEVICE (MODEL 37602/37603 OR 37601) WERE USED, BUT THE AUTHORS MODIFIED THE DEVICES BY OPENING UP THE CIRCUIT BOARD TO PROVIDE "ABNORMAL" STIMULATION SETTINGS. 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 REPORTED THAT THE NOVEL SETTINGS TESTED OVER A FEW MINUTES SOMETIMES ELICITED TEMPORARY BUT PREDICTABLE PARASTHESIAS OR OTHER MILD SIDE EFFECTS. THEY NOTED THAT IN 2 CASES THE PATIENTS REQUESTED THE STIMULATION SETTINGS BE TURNED OFF, BUT IN ALL CASES THE SIDE EFFECT WAS TEMPORARY, LASTING SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627971 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR