BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6247782 · Received January 12, 2017

    Report

    Report Number
    3007566237-2017-00120
    Event Type
    Injury
    Date Received
    January 12, 2017
    Date of Event
    January 3, 2017
    Report Date
    January 12, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. 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

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

    Description of Event or Problem · 1

    OSTREM JL, SAN LUCIANO M, DODENHOFF KA, ZIMAN N, MARKUN LC, RACINE CA, DE HEMPTINNE C, VOLZ MM, HEATH SL, STARR PA. SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION IN ISOLATED DYSTONIA: A 3-YEAR FOLLOW-UP STUDY. NEUROLOGY 2017; 88:1-11 SUMMARY: THE OBJECTIVE OF THIS STUDY WAS TO REPORT LONG-TERM SAFETY AND EFFICACY OUTCOMES OF A LARGE COHORT OF PATIENTS WITH MEDICALLY REFRACTORY ISOLATED DYSTONIA TREATED WITH SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS). PATIENT 14: ONE (B)(6) MALE PATIENT WITH SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) FOR DYSTONIA EXPERIENCED MINOR TRAUMA TO THE SKIN OVER THE IMPLANTABLE NEUROSTIMULATOR (INS) AND SUBSEQUENTLY DEVELOPED A DEVICE-RELATED INFECTION AT 15 MONTHS AFTER IMPLANT. THIS REQUIRED EXPLANT OF THE DBS SYSTEM AND RESOLVED. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3389; IMPLANTABLE NEUROSTIMULATOR KINETRA; IMPLANTABLE NEUROSTIMULATOR ACTIVA PC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29868 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention