BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 10998830 · Received December 13, 2020

    Report

    Report Number
    2182207-2020-01470
    Event Type
    Injury
    Date Received
    December 13, 2020
    Date of Event
    September 12, 2020
    Report Date
    December 11, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STERN MA, ISBAINE F, QIU D, RILEY JP, BOULIS NM, GROSS RE. RADIOFREQUENCY ABLATION THROUGH PREVIOUSLY EFFECTIVE DEEP BRAIN STIMULATION LEADS FOR PARKINSON DISEASE: A RETROSPECTIVE SERIES. WORLD NEUROSURG. 2020. 10.1016/J.WNEU.2020.09.060. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: 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 THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION 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

    STERN MA, ISBAINE F, QIU D, RILEY JP, BOULIS NM, GROSS RE. RADIOFREQUENCY ABLATION THROUGH PREVIOUSLY EFFECTIVE DEEP BRAIN STIMULATION LEADS FOR PARKINSON DISEASE: A RETROSPECTIVE SERIES. WORLD NEUROSURG. 2020. 10.1016/J.WNEU.2020.09.060. SUMMARY: ALTHOUGH DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS (STN) OR GLOBUS PALLIDUS INTERNUS (GPI) IS THE SURGICAL METHOD OF CHOICE TO TREAT THE CANONICAL SYMPTOMS OF PARKINSON DISEASE, OCCASIONALLY SURGICAL SITES BECOME INFECTED OR THE HARDWARE ERODES, NECESSITATING EXPLANTATION. USUAL PRACTICE IS TO REMOVE AND REIMPLANT REPLACEMENT LEADS AFTER TISSUE HEALING, LEAVING PATIENTS WITHOUT THE CLINICAL BENEFITS OF DBS FOR SEVERAL MONTHS, AND AT RISK FOR DBS WITHDRAWAL IN SOME, AND SOME PATIENTS ARE NO LONGER GOOD SURGICAL CANDIDATES FOR REIMPLANTATION. RADIOFREQUENCY ABLATION THROUGH THE DBS LEAD IS AN OPTION FOR THESE PATIENTS IDENTIFIED EVENTS: 30 PATIENTS HAVE UNDERGONE A SYSTEM EXPLANT DUE TO INFECTION. 15 OF THESE PATIENTS UNDERWENT REIMPLANTATION. 3 PATIENTS HAD HARDWARE REVISION OR REPLACEMENT, WHILE 4 PATIENTS HAD WOUND DEBRIDEMENT. 1 PATIENT HAD EROSION AT INS SITE SECONDARY TO EMACIATED BODY HABITUS, WHICH LED TO THE INS BEING REVISED AND REPOSITIONED. THE P ATIENT HAD RECURRENT EROSION AND INFECTION, DEBRIDEMENT, SCALP ADVANCEMENT AND SKIN GRAFT FAILED. THE SYSTEM WAS REMOVED. 1 PATIENT HAD A LEAD REVISION, THEN THE INS BECAME INFECTED LATER. AFTER THE INFECTION, THE INS WAS REPLACED. THE PATIENT HAD EROSION WITH SCAR/SCABBING OVER EXTENSION CABLES, WHICH LED TO REINTERNALIZATION AND DEBRIDEMENT, INFECTION OF DBS LEADS, AND ULTIMATELY A REMOVAL OF THE SYSTEM. 1 PATIENT EXPERIENCED LEAD EXPOSURE AT CONNECTION SITE, AND AN INFECTION AND SCABBING OVER THE CONNECTION SITE. THE SYSTEM WAS EX PLANTED. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464568 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention