BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5659806 · Received May 17, 2016

    Report

    Report Number
    3007566237-2016-02004
    Event Type
    Injury
    Date Received
    May 17, 2016
    Date of Event
    January 28, 2003
    Report Date
    May 17, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387, PRODUCT TYPE: LEAD. THE FOLLOWING SPECIFIC DEVICE INFORMATION WAS PROVIDED IN THE ARTICLE: LEAD MODEL 3387, IMPLANTABLE NEUROSTIMULATOR SYNERGY, AND IMPLANTABLE NEUROSTIMULATOR DUAL CHANNEL ITREL, 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.

    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

    YIANNI, J., BAIN, P.G., GREGORY, R.P., NANDI, D., JOINT, C., SCOTT, R.B., STEIN, J.F., AZIZ, T.Z. POST-OPERATIVE PROGRESS OF DYSTONIA PATIENTS FOLLOWING GLOBUS PALLIDUS INTERNUS DEEP BRAIN STIMULATION. EUROPEAN JOURNAL OF NEUROLOGY. (2003) 10: 239-247. SUMMARY: IN THE CURRENT ERA OF FUNCTIONAL SURGERY FOR MOVEMENT DISORDERS, DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS (GPI) IS EMERGING AS THE FAVOURED INTERVENTION FOR PATIENTS WITH DYSTONIA. HERE WE REPORT OUR RESULTS IN 20 PATIENTS WITH MEDICALLY INTRACTABLE DYSTONIA TREATED WITH GPI STIMULATION. THE SERIES COMPRISED 14 PATIENTS WITH GENERALIZED DYSTONIA AND SIX WITH SPASMODIC TORTICOLLIS. ALTHOUGH COMPARISONS WERE LIMITED BY DIFFERENCES IN THEIR RESPECTIVE NEUROLOGICAL RATING SCALES, CHRONIC DBS CLEARLY BENEFITED BOTH PATIENT GROUPS. DATA CONVEYING THE RATE OF CHANGE IN NEUROLOGICAL FUNCTION FOLLOWING INTERVENTION ARE ALSO PRESENTED, DEMONSTRATING THE GRADUAL BUT PROGRESSIVE AND SUSTAINED NATURE OF IMPROVEMENT FOLLOWING STIMULATION OF THE GPI IN DYSTONIC PATIENTS. REPORTED EVENTS: ONE (B)(6) FEMALE PATIENT WITH GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR DYSTONIA EXPERIENCED A REBOUND PHENOMENON, EITHER DUE TO A DAMAGED LEAD CONNECTOR, OR DUE TO THE PULSE GENERATOR BATTERY RUNNING OUT SUDDENLY. THE PATIENT BEGAN TO RECOVER RAPIDLY WITHIN A FEW HOURS OF THE APPROPRIATE HARDWARE BEING REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314286 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Life Threatening| R