BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3397444 · Received October 9, 2013

    Report

    Report Number
    3007566237-2013-03306
    Event Type
    Injury
    Date Received
    October 9, 2013
    Date of Event
    November 18, 2011
    Report Date
    September 24, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. OFF LABEL USE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    MARKS, W., BAILEY, L., REED, M., POMYKAL, A., MERCER, M., MACOMBER, D., ACOSTA, F., HONEYCUTT, J. PALLIDAL STIMULATION IN CHILDREN: COMPARISON BETWEEN CEREBRAL PALSY AND DYT1 DYSTONIA. JOURNAL OF CHILD NEUROLOGY. 2013;28(7):840-848. DOI:10.1177/0883073813488674 SUMMARY: THE AUTHORS COMPARED THE OUTCOMES OF 17 CHILDREN AGED 7 TO 15 YEARS WITH DYT1 DYSTONIA OR CEREBRAL PALSY FOLLOWING DEEP BRAIN STIMULATION. WHILE PATIENTS WITH CEREBRAL PALSY PRESENTED WITH SIGNIFICANTLY GREATER MOTOR DISABILITY THAN THE DYT1 COHORT AT BASELINE, BOTH GROUPS DEMONSTRATED IMPROVEMENT AT 1 YEAR (CEREBRAL PALSY ¼ 24%; DYT1 ¼ 6%). THE GROUP AS A WHOLE DEMONSTRATED SIGNIFICANT IMPROVEMENT ON THE BARRY-ALBRIGHT DYSTONIA SCALE ACROSS TIME. GAINS IN MOTOR FUNCTION WERE APPARENT IN BOTH AXIAL AND APPENDICULAR DISTRIBUTIONS INVOLVING BOTH UPPER AND LOWER EXTREMITIES. GAINS ACHIEVED BY 6 MONTHS WERE SUSTAINED IN THE CEREBRAL PALSY GROUP, WHEREAS THE DYT1 GROUP DEMONSTRATED CONTINUED IMPROVEMENT WITH ONGOING PALLIDAL STIMULATION BEYOND 18 MONTHS. YOUNG PATIENTS WITH DYSTONIA DUE TO CEREBRAL PALSY RESPONDED COMPARABLY TO PATIENTS WITH DYT1 DYSTONIA. THE SEVERITY OF MOTOR IMPAIRMENT IN PATIENTS WITH CEREBRAL PALSY AT BASELINE AND FOLLOW-UP RAISES THE ISSUE OF EVEN EARLIER INTERVENTION WITH NEUROMODULATION IN THIS POPULATION TO LIMIT LONG-TERM MOTOR IMPAIRMENTS DUE TO DYSTONIA. REPORTED EVENTS: A (B)(6) PATIENT WITH CEREBRAL PALSY HAD INFECTION AND HARDWARE REMOVAL. THIS EVENT WAS PREVIOUSLY REPORTED IN MANUFACTURING REPORT # 3007566237-2013-02622. ANY ADDITIONAL INFORMATION RECEIVED REGARDING TH IS EVENT WILL NOW BE REPORTED USING THE NEW MANUFACTURING REPORT #. THE INITIAL REPORTER ALSO REPORTED THE EVENT IN MANUFACTURING REPORT # 1750369203-2011-0007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511730 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR Required Intervention