BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3271785 · Received August 8, 2013

    Report

    Report Number
    3007566237-2013-02622
    Event Type
    Injury
    Date Received
    August 8, 2013
    Date of Event
    April 7, 2013
    Report Date
    July 19, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    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. PRODUCT ID: 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (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 TOLIMIT LONG-TERM MOTOR IMPAIRMENTS DUE TO DYSTONIA. REPORTED EVENTS: 1. 2 PATIENTS WITH CEREBRAL PALSY HAD INFECTION AND HARDWARE REMOVAL. 2. 1 PATIENT WITH DYSTONIA UNDERWENT LEAD RELOCATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    PREVIOUSLY, IT WAS REPORTED THAT TWO PATIENTS WITH CEREBRAL PALSY HAD INFECTION AND HARDWARE REMOVAL AND ONE PATIENT WITH DYSTONIA UNDERWENT A LEAD RELOCATION. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THESE EVENTS AND SEPARATE MANUFACTURING REPORTS WERE FILED ON THEM. GOING FORWARD, INFORMATION RECEIVED REGARDING THESE EVENTS WILL BE REPORTED UNDER ONE OF THE FOLLOWING MANUFACTURING REPORT NUMBERS: PATIENT 1 INFECTION: 3007566237-2013-03306, PATIENT 2 INFECTION: 3004209178-2013-17756, PATIENT 2 INFECTION: 3004209178-2013-17757, PATIENT 2 INFECTION: 3007566237-2013-03309, PATIENT 2 INFECTION: 3004209178-2013-17758, LEAD RELOCATION: 3004209178-2013-17760, LEAD RELOCATION: 3004209178-2013-17761.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374216 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention