BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 11392960 · Received March 1, 2021

    Report

    Report Number
    2182207-2021-00333
    Event Type
    Injury
    Date Received
    March 1, 2021
    Date of Event
    December 13, 2020
    Report Date
    March 1, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAVALLIERI, F., FRAIX, V., BOVE, F., MULAS, D., TONDELLI, M., CASTRIOTO, A., KRACK, P., MEONI, S., SCHMITT, E., LHOMMEE, E., BICHON, A., PELISSIER, P., CHEVRIER, E., KISTNER, A., SEIGNEURET, E., CHABARDES, S., & MORO, E. (2020). PREDICTORS OF LONG-TERM OUTCOME OF SUBTHALAMIC STIMULATION IN PARKINSON DISEASE. AMERICAN NEUROLOGICAL ASSOCIATION. DOI: 10.1002/ANA.25994. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. 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. DATE OF EVENT. 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. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CAVALLIERI, F., FRAIX, V., BOVE, F., MULAS, D., TONDELLI, M., CASTRIOTO, A., KRACK, P., MEONI, S., SCHMITT, E., LHOMMEE, E., BICHON, A., PELISSIER, P., CHEVRIER, E., KISTNER, A., SEIGNEURET, E., CHABARDES, S., & MORO, E. (2020). PREDICTORS OF LONG-TERM OUTCOME OF SUBTHALAMIC STIMULATION IN PARKINSON DISEASE. AMERICAN NEUROLOGICAL ASSOCIATION. DOI: 10.1002/ANA.25994 SUMMARY: SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STNDBS) IS AN EFFECTIVE TREATMENT IN BOTH THE SHORT- AND LONG-TERM FOLLOW-UP FOR PATIENTS WITH ADVANCED PARKINSON DISEASE (PD). THE SUCCESS OF STN-DBS SURGERY RELIES ON ACCURATE PATIENT SELECTION, BRAIN TARGETING PRECISION, OPTIMIZED DBS PROGRAMMING, AND MEDICATION MANAGEMENT AFTER SURGERY. PREDICTIVE FACTORS OF POSTOPERATIVE OUTCOME ARE CRUCIAL IN THE SELECTION PHASE OF THE SURGICAL PROCESS. THE PREOPERATIVE RESPONSE TO L-DOPA HAS BEEN CRITICAL TO DECIDE PATIENT CANDIDACY FOR SURGERY, BEING CONSIDERED THE BEST PREDICTIVE FACTOR OF SHORT-TERM POSTOPERATIVE MOTOR RESPONSE. OTHER SHORT-TERM POSITIVE PREOPERATIVE PREDICTIVE FACTORS HAVE BEEN YOUNGER AGE AT SURGERY, HIGHER UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS) MOTOR SCORES IN THE OFF-MEDICATION CONDITION, LONGER DISEASE DURATION, AND TREMOR DOMINANT (TD) PD PHENOTYPE. IDENTIFIED EVENTS: 18 PATIENTS HAD SURGICAL COMPLICATIONS RESPONSIBLE FOR PERSISTENT NEUROLOGICAL SEQUELAE, SUCH AS INTRACEREBRAL OR INTRAVENTRICULAR HEMORRHAGE, ISCHEMIC INFARCTION, AND EXTRADURAL HEMATOMA. 14 PATIENTS HAD AN ELECTRODE MISPLACEMENT. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: 7424 ITREL II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290159 ITREL II STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7424

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention