BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7639744 · Received June 26, 2018

    Report

    Report Number
    3007566237-2018-01903
    Event Type
    Injury
    Date Received
    June 26, 2018
    Date of Event
    April 17, 2018
    Report Date
    June 26, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    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 THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN. DIESTRO, JDB., VESAGAS, TS., TELEG, RA., AGUILAR, JA., ANLACAN, JP., JAMORA, RDG. DEEP BRAIN STIMULATION FOR PARKINSON'S DISEASE IN THE PHILIPPINES: OUTCOMES OF THE PHILIPPINE MOVEMENT DISORDER SURGERY CENTER. WORLD NEUROSURG. 2018. DOI: 10.1016/J.WNEU.2018.04.125. 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 ESTABLISHED TREATMENT MODALITY FOR PARKINSON DISEASE (PD). THE FIRST DBS FOR PD IN THE PHILIPPINES WAS PERFORMED AT THE PHILIPPINE MOVEMENT DISORDER SURGERY CENTER IN 2006. THERE ARE NO PHILIPPINE DATA ON DBS FOR PD. WE AIM TO DETERMINE THE MOTOR IMPROVEMENT AND REDUCTION IN MEDICATION DOSAGE OF ALL PATIENTS WITH PD WHO UNDERWENT DBS AT THE PHILIPPINE MOVEMENT DISORDER SURGERY CENTER. - METHODS: THIS IS A RETROSPECTIVE STUDY OF ALL PATIENTS WITH PD (N = 17) WHO UNDERWENT DBS FROM 2006 TO 2016. THE CHANGE IN THE UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS) MOTOR AND LEVODOPA EQUIVALENT DOSE WERE DETERMINED. - RESULTS: THERE WAS A STATISTICALLY SIGNIFICANT REDUCTION IN THE UPDRS MOTOR IN ALL PATIENTS OFF MEDICATION AT 3 MONTHS (48.2%; P = 0.004), 1 YEAR (47.3%; P = 0.026), 2 YEARS (48.4%; P = 0.021), AND 3 YEARS (66.0%; P = 0.032) AFTER DBS AND ON MEDICATION AT 3 MONTHS (43.3%; P [ 0.023), 6 MONTHS (24.7%; P = 0.053), AND 1 YEAR (38.1%; P = 0.033). A SIGNIFICANT REDUCTION IN THE DOSAGE OF PD MEDICATIONS WAS ALSO SEEN UNTIL THE SECOND YEAR OF FOLLOWUP (52.3%; P <(><<)> 0.001). ADVERSE EVENTS INCLUDED AN ATTEMPTED SUICIDE AND A DEVICE-RELATED INFECTION. -CONCLUSIONS: DBS FOR PD IMPROVES THE UPDRS MOTOR SCORE IN THE OFF-MEDICATION AND ON-MEDICATION STATE, WITH THE MAXIMAL BENEFIT SEEN AT 3 YEARS AFTER SURGERY AND REDUCES PD MEDICATION DOSAGE BY HALF. ALTHOUGH THE BENEFIT FROM DBS IS UNDENIABLE, THE HIGH COST OF THE PROCEDURE PRECLUDES MORE PATIENTS FROM BENEFITTING FROM IT. THERE IS A NEED FOR GOVERNMENT SUPPORT TO EXPAND ACCESS TO DBS. REPORTED EVENTS: PLI 10: A MALE PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) ATTEMPTED SUICIDE BY HANGING 5 MONTHS AFTER RECEIVING DBS. THE PATIENT WAS REPORTEDLY REFERRED TO A PSYCHIATRIST FOR MANAGEMENT, HOWEVER THEY AGAIN ATTEMPTED SUICIDE BY INGESTION OF LYE 5 MONTHS LATER. AS OF THE DATE OF PUBLICATION THERE HAD REPORTEDLY BEEN NO FURTHER SUICIDE ATTEMPTS. PLI 20-30: A MALE PATIENT WITH DBS FOR PD EXPERIENCED A DEVICE-RELATED INFECTION CHARACTERIZED BY SKIN EROSION AND GRANULOMA OF THE SCALP OVER THE LEAD CONNECTOR SITE 6 MONTHS AFTER SURGERY. THE WOUND CULTURE WAS POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS. THE PATIENT UNDERWENT SKIN DEBRIDEMENT, REMOVAL OF THE LEAD CONNECTORS, AND ANTIBIOTIC THERAPY TO ADDRESS HIS DEVICE-RELATED INFECTION. HOWEVER, HE WAS NOTED TO HAVE A RECURRENCE OF THE DEVICE-RELATED INFECTION AT THE SAME SITE AT 11 MONTHS AFTER REIMPLANTATION OF THE LEAD CONNECTORS. HE IS NOW INFECTION FREE AFTER ANTIBIOTIC TREATMENT WITH THE DEVICE STILL IMPLANTED AND FUNCTIONAL. PATIENTS WERE REPORTEDLY IMPLANTED WITH MODEL 3389 MODEL LEADS AND EITHER MODEL 7428 KINETRA OR 37612 ACTIVA RC NEUROSTIMULATORS. IT WAS NOT POSSIBLE TO ASCERTAIN ANY FURTHER 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
    480319 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R