BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8422390 · Received March 14, 2019

    Report

    Report Number
    3007566237-2019-00626
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    January 17, 2019
    Report Date
    March 14, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH: THIS VALUE IS THE AVERAGE AGE 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. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. SESAR A, FERNANDEZ-PAJARIN G, ARES B,RELOVA, JL., ARAN, E., RIVAS, MT., GELABERT-GONZALEZ, M., CASTRO, A. "CONTINUOUS SUBCUTANEOUS APOMORPHINE IN ADVANCED PARKINSON'S DISEASE PATIENTS TREATED WITH DEEP BRAIN STIMULATION." J NEUROL. 2019. DOI: 10.1007/S00415-019-09184-5. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: DEEP BRAIN STIMULATION (DBS) IS AN EFFECTIVE THERAPY FOR PATIENTS WITH ADVANCED PARKINSON¿S DISEASE (PD). HOWEVER, SOMETIMES, IT IS NOT SUFFICIENT TO ADEQUATELY CONTROL MOTOR SYMPTOMS. WE DESCRIBE OUR EXPERIENCE WITH CONTINUOUS SUBCUTANEOUS APOMORPHINE INFUSION (APO) IN PATIENTS WITH DBS. METHODS WE UNDERTOOK A RETROSPECTIVE ANALYSIS OF ALL PATIENTS TREATED WITH DBS AND APO AT OUR CENTRE OVER 12 YEARS. SUBJECTS WERE ALLOCATED TO FOUR GROUPS: (1) APO TEMPORARILY BEFORE DBS, (2) APO AFTER DBS COMPLICATIONS BEFORE A NEW DBS, (3) APO AFTER DEFINITIVE DBS REMOVAL, AND (4) APO IN PATIENTS WITH DBS AND DECLINING RESPONSE. MOTOR STATE AND OTHER PARAMETERS WERE ANALYSED AND COMPARED FOR THE DIFFERENT TREATMENTS. RESULTS DATA FOR 71 PATIENTS WERE EVALUATED. GROUP 1: (N = 18) PATIENTS IMPROVED THEIR MOTOR FUNCTION SIGNIFICANTLY WITH BOTH APO AND DBS (OFF-HOURS BEFORE APO 5.4 ± 1.4; AFTER APO 1.4 ± 1.2, P > 0.001; AFTER DBS 0.7 ± 0.8, P 0.001). GROUP 2: (N = 11) PATIENTS WERE FOUND TO HAVE MILD BUT SIGNIFICANT WORSENING OF MOTOR STATE BETWEEN THE FIRST DBS TREATMENT (OFF HOURS 0.7 ± 1.0) AND APO (2.2 ± 1.5, P = 0.02), AND IMPROVEMENT BETWEEN APO AND THE SECOND DBS TREATMENT (OFF-HOURS 0.6 ± 0.8, P = 0.03). GROUP 3: (N = 12) PATIENTS HAD MILD BUT SIGNIFICANT WORSENING OF MOTOR FUNCTION BETWEEN DBS (OFF-HOURS 1.1 ± 1.0) AND APO (2.0 ± 0.9, P = 0.03). GROUP 4: (N = 13) SIGNIFICANT IMPROVEMENT IN MOTOR FUNCTION WAS OBSERVED BETWEEN DBS ALONE (OFF-HOURS 3.9 ± 2.6) AND DBS COMBINED WITH APO (2.2 ± 1.3, P = 0.03). CONCLUSION IN ADVANCED PD, DBS MAY BE NOT SUFFICIENT OR MAY FAIL TO CONTROL MOTOR SYMPTOMS ADEQUATELY. IN THESE CASES, APO, WHETHER ALONE OR IN COMBINATION WITH DBS, IS A GOOD CHOICE TO IMPROVE THE DISEASE CONTROL. REPORTED EVENTS: 8 PATIENTS WHO HAD BEEN SUCCESSFULLY TREATED WITH DBS FOR PARKINSON'S DISEASE (PD) EXPERIENCED AN INFECTION THAT REQUIRED A TEMPORARY DEVICE REMOVAL. THE AUTHORS STATED THAT THEY OBSERVED VERY SEVERE OFF-STATES THAT WERE UNRESPONSIVE TO ORAL MEDICATION IN PATIENTS THAT REQUIRED CESSATION OF DBS. 11 PATIENTS WITH DBS FOR PD EXPERIENCED AN INFECTION THAT RESULTED IN PERMANENT DEVICE REMOVAL. THE AUTHORS STATED THAT THEY OBSERVED VERY SEVERE OFF-STATES THAT WERE UNRESPONSIVE TO ORAL MEDICATION IN PATIENTS THAT REQUIRED CESSATION OF DBS. 2 PATIENTS WITH DBS FOR PD UNDERWENT PERMANENT DEVICE REMOVAL FOR UNSPECIFIED REASONS. THE AUTHORS STATED THAT THEY OBSERVED VERY SEVERE OFF-STATES THAT WERE UNRESPONSIVE TO ORAL MEDICATION IN PATIENTS THAT REQUIRED CESSATION OF DBS. 3 PATIENTS WITH DBS FOR PD EXPERIENCED AN ELECTRODE BREAK THAT REQUIRED A TEMPORARY DEVICE REMOVAL. THE AUTHORS INDICATED THAT THESE PATIENTS WERE ALL EVALUATED IN SITUATIONS WHERE THEY HAD ONE OR NO ELECTRODE WORKING. THE AUTHORS STATED THAT THEY OBSERVED VERY SEVERE OFF-STATES THAT WERE UNRESPONSIVE TO ORAL MEDICATION IN PATIENTS THAT REQUIRED CESSATION OF DBS. A PATIENT WITH DBS FOR PD EXPERIENCED A CYST SURROUNDING THE ELECTRODE THAT REQUIRED A TEMPORARY DEVICE REMOVAL. THE AUTHORS INDICATED THAT THESE PATIENTS WERE ALL EVALUATED IN SITUATIONS WHERE THEY HAD ONE OR NO ELECTRODE WORKING. THE AUTHORS STATED THAT THEY OBSERVED VERY SEVERE OFF-STATES THAT WERE UNRESPONSIVE TO ORAL MEDICATION IN PATIENTS THAT REQUIRED CESSATION OF DBS. 1 PATIENT WITH DBS FOR PD EXPERIENCED AN ELECTRODE DISPLACEMENT THAT REQUIRED DEVICE REMOVAL. THE AUTHORS STATED THAT THEY OBSERVED VERY SEVERE OFF-STATES THAT WERE UNRESPONSIVE TO ORAL MEDICATION IN PATIENTS THAT REQUIRED CESSATION OF DBS. 2 PATIENTS WITH DBS FOR PD REPORTEDLY EXPERIENCED AN IMMEDIATE LACK OF RESPONSE TO DBS DESPITE ATTEMPTS AT REPROGRAMMING AND UNDERWENT AN ADDITIONAL INTERVENTION TO CHANGE ELECTRODE POSITION. THESE PATIENTS WERE ULTIMATELY TREATED WITH A COMBINATION DBS AND CONTINUOUS SUBCUTANEOUS APOMORPHINE INFUSION WHICH LED TO A SIGNIFICANT DECREASE IN DAILY OFF HOURS IN AN UNKNOWN NUMBER OF PATIENTS. THE AUTHORS PROVIDED CONFLICTING NUMBERS, FIRST STATING THAT 18 PATIENTS RECEIVED APOMORPHINE INFUSION DUE TO LOSS OR LACK OF DBS EFFICACY, BUT PROVIDING DETAILS REGARDING A TOTAL OF 20 APPARENT CASES. 2 PATIENTS WITH DBS FOR PD REPORTEDLY HAD EXPERIENCED A LOSS OF RESPONSE TO DBS AND UNDERWENT AN ADDITIONAL SURGERY WHEN THEIR ¿FAVORABLE RESPONSE SUBSIDED.¿ THESE PATIENTS RESPONDED WELL TO THE THERAPY FOR BETWEEN 18-132 MONTHS BUT EXPERIENCED A LOSS OF RESPONSE DESPITE ATTEMPTS AT REPROGRAMMING. THESE PATIENTS WERE ULTIMATELY TREATED WITH A COMBINATION DBS AND CONTINUOUS SUBCUTANEOUS APOMORPHINE INFUSION WHICH LED TO A SIGNIFICANT DECREASE IN DAILY OFF HOURS IN AN UNKNOWN NUMBER OF PATIENTS. THE AUTHORS PROVIDED CONFLICTING NUMBERS, FIRST STATING THAT 18 PATIENTS RECEIVED APOMORPHINE INFUSION DUE TO LOSS OR LACK OF DBS EFFICACY, BUT PROVIDING DETAILS REGARDING A TOTAL OF 20 APPARENT CASES. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215697 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention