BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2387590 · Received December 23, 2011

    Report

    Report Number
    3007566237-2011-09338
    Event Type
    Injury
    Date Received
    December 23, 2011
    Report Date
    November 23, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNK IMPLANTED: UNK, EXPLANTED: UNK. LEAD: MODEL NEU_UNKNOWN. LEAD: LOT# UNKNOWN, SERIAL# UNK, IMPLANTED: UNK, EXPLANTED: UNK. LEAD: MODEL NEU_UNKNOWN. EXT: LOT# UNK, SERIAL# UNKNOWN, IMPLANTED: UNK, EXPLANTED: UNK. LEAD: MODEL NEU_UNKNOWN. EXT: LOT# UNK, SERIAL# UNKNOWN, IMPLANTED: UNK, EXPLANTED: UNK.

    Description of Event or Problem · 1

    REAL, R., LINHARES, P., FERNANDES, H., ROSAS, M. J., GAGO, M., F., PEREIRA, J., VAZ, R. ROLE OF TC-SULESOMAB IMMUNOSCINTIGRAPHY IN THE MANAGEMENT OF INFECTION FOLLOWING DEEP BRAIN STIMULATION SURGERY. NEUROL RESEARCH INTERNATIONAL. 2011;2011:817951. DOI: 10.11 55/2011/817951. SUMMARY: THE AUTHORS EVALUATE THE POTENTIAL ROLE OF IMMUNOSCINTIGRAPHY WITH TC-LABELLED ANTIGRANULOCYTE ANTIBODY FRAGMENTS (TC-SULESOMAB) IN THE MANAGEMENT OF INFECTION IN PARKINSON'S DISEASE (PD) PATIENTS FOLLOWING DEEP BRAIN STIMULATION (DBS), THE PRESENCE OF WHICH CORRELATES WITH THE EXTENT OF INFECTION, THUS I) ALLOWING THE DIFFERENTIATION OF PATIENTS WHO SHOULD REMOVE THE ENTIRE SYSTEM VS. THOSE WHO COULD RECEIVE A MORE CONSERVATIVE TREATMENTS; AND II) HELPING TO DETERMINE THE MOST APPROPRIATE TIMING FOR RE-IMPLANTATION. THIS STUDY LOOKED AT 8 PATIENTS WITH PD WHO HAD BEEN IMPLANTED WITH BILATERAL DBS IN THE SUBTHALAMIC NUCLEUS (STN) BETWEEN (B)(6) 2002 AND (B)(6) 2008 AND HAD PERSISTENT DEVICE-RELATED SKIN EROSION AND/OR INFECTION. THE LEADS AND STIMULATOR WERE PLACED IN A SINGLE STAGE PROCEDURE. EACH PATIENT EXPERIENCED SKIN EROSION AND/OR INFECTION THAT WAS TREATED WITH ANTIBIOTICS, BUT HAD PERSISTENT OR RECURRENT WOUND DEHISCENCE. IMMUNOSCINTIGRAPHY WAS THEN PERFORMED BETWEEN (B)(6) 2009 AND (B)(6) 2010 AND EACH PATIENT WAS THEN SUBJECTED TO WOUND DEBRIDEMENT ALONE OR IN COMBINATION WITH EITHER PARTIAL OR COMPLETE HARDWARE REMOVAL. REPORTED EVENT: A MALE PATIENT WHO WAS IMPLANTED WITH DBS FOR PD AT THE AGE OF 64 PRESENTED WITH WOUND DEHISCENCE OF THE RETROAURICULAR INCISION AND THE SKIN ALONG THE EXTENSION CABLES PATHWAY IN THE NECK. THE PATIENT HAD A (B)(6), HAD BEEN TREATED WITH ANTIBIOTICS AND HAD ONE SURGERY PRIOR TO THE STUDY IN WHICH THE IPG AND EXTENSION CABLES WERE REMOVED. BECAUSE OF THE PERSISTENT OR RECURRENT WOUND DEHISCENCE A TC-SULESOMAB IMMUNOSCINTIGRAPHY WAS PERFORMED. THE TC-SULESOMAB IMMUNOSCINTIGRAPHY SHOWED DIFFUSE UPTAKE (BILATERAL FRONTAL AND RETROAURICULAR). A SURGERY WAS PERFORMED DURING WHICH PURULENT EXUDATE WAS FOUND OVER THE BURR HOLE CAPS AND ALONG THE EXTRACRANIAL TRAJECTORY OF ELECTRODES. BOTH ELECTRODES WERE REMOVED. THE INFECTION HEALED. AT A THREE MONTH FOLLOW-UP THE PATIENT UNDERWENT A REPEAT IMMUNOSCINTIGRAPHY SCAN WHICH WAS POSITIVE FOR INCREASED TC-LABELED SULESOMAB, AND THE PATIENT WAS NOT RE-IMPLANTED. SEE LITERATURE ARTICLE ATTACHED IN MFR REPORT# 3007566237-2011-09329.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL#