BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 9157877 · Received October 4, 2019

    Report

    Report Number
    3007566237-2019-02073
    Event Type
    Injury
    Date Received
    October 4, 2019
    Date of Event
    August 21, 2019
    Report Date
    October 4, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, IMPLANT/EXPLANT: UNKNOWN; PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN, IMPLANT/EXPLANT: UNKNOWN. MOSTOFI A, EVANS JM, PARTINGTON-SMITH L, YU K, CHEN C, SILVERDALE MA. OUTCOMES FROM DEEP BRAIN STIMULATION TARGETING SUBTHALAMIC NUCLEUS AND CAUDAL ZONA INCERTA FOR PARKINSON'S DISEASE. NPJ PARKINSONS DIS. 2019;5:17. 10.1038/S41531-019-0089-1. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ABSTRACT: BOTH SUBTHALAMIC NUCLEUS (STN) AND CAUDAL ZONA INCERTA (CZI) HAVE BEEN IMPLICATED AS THE OPTIMAL LOCUS FOR DEEP BRAIN STIMULATION (DBS) IN PARKINSON¿S DISEASE (PD). WE PRESENT A RETROSPECTIVE CLINICO-ANATOMICAL ANALYSIS OF OUTCOMES FROM DBS TARGETING BOTH STN AND CZI. FORTY PATIENTS UNDERWENT BILATERAL DBS USING AN IMAGE-VERIFIED IMPLANTABLE GUIDE TUBE/STYLETTE TECHNIQUE. CONTACTS ON THE SAME QUADRIPOLAR LEAD WERE PLACED IN BOTH STN AND CZI. AFTER PULSE GENERATOR PROGRAMMING, CONTACTS YIELDING THE BEST CLINICAL EFFECT WERE SELECTED FOR CHRONIC STIMULATION. OFF MEDICATION UNIFIED PD RATING SCALE (UPDRS) PART III SCORES PRE-OPERATIVELY AND ON STIMULATION AT 1¿2 YEAR FOLLOW UP WERE COMPARED. ACTIVE CONTACTS AT FOLLOW-UP WERE ANATOMICALLY LOCALISED FROM PERI-OPERATIVE IMAGING. OVERALL, MEAN UPDRS PART III SCORE IMPROVEMENT WAS 55 ± 9% (95% CONFIDENCE INTERVAL), WITH IMPROVEMENT IN SUBSCORES FOR RIGIDITY (59 ± 13%), BRADYKINESIA (58 ± 13%), TREMOR (71 ± 24%) AND AXIAL FEATURES (36 ± 19%). ACTIVE CONTACTS WERE DISTRIBUTED IN THE FOLLOWING LOCATIONS: (1) WITHIN POSTERIOR/DORSAL STN (50%); (2) DORSAL TO STN (24%); (3) IN CZI (21%); AND (4) LATERAL TO STN (5%). WHEN CONTACTS WERE GROUPED BY LOCATION, NO SIGNIFICANT DIFFERENCES BETWEEN GROUPS WERE SEEN IN BASELINE OR POST-OPERATIVE IMPROVEMENT IN CONTRALATERAL UPDRS PART III SUBSCORES. WE CONCLUDE THAT WHEN BOTH STN AND CZI ARE TARGETED, ACTIVE CONTACTS ARE DISTRIBUTED MOST COMMONLY WITH IN AND IMMEDIATELY DORSAL TO STN. IN A SUBGROUP OF CASES, CZI CONTACTS WERE SELECTED FOR CHRONIC STIMULATION IN PREFERENCE. DUAL TARGETING OF STN AND CZI IS FEASIBLE AND MAY PROVIDE EXTRA BENEFIT COMPARED WITH CONVENTIONAL STN DBS IS SOME PATIENTS. REPORTED EVENTS: 2 PATIENTS UNDERWENT SKIN EROSION AT THE PECTORAL INS SITE REQUIRING INS REMOVAL. 1 PATIENT EXPERIENCED SKIN EROSION MANAGED SURGICALLY AND WITH PROLONGED INTRAVENOUS ANTIBIOTICS WITHOUT INS REMOVAL. 1 PATIENT HAD A SECOND PROCEDURE TO RE-IMPLANT THE GUIDE TUBES THAT WERE INACCURATELY PLACED DUE TO INTRA-OPERATIVE DISPLACEMENT OF THE STEREOTACTIC FRAME. THE FOLLOWING DEVICE SPECIFICS WERE MENTIONED: INS MODELS 37601 AND 7428, AND LEAD MODEL 3389.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951528 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention