BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4680561 · Received April 10, 2015

    Report

    Report Number
    3007566237-2015-00953
    Event Type
    Injury
    Date Received
    April 10, 2015
    Date of Event
    July 4, 2014
    Report Date
    March 19, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3389-40, LOT# 0207215339, PRODUCT TYPE: LEAD. PRODUCT ID: 3389-40, LOT# 0 207038199, PRODUCT TYPE: LEAD. PRODUCT ID: 3389-40, LOT# 0207215339, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    ZSIGMOND, P., GORANSSON, N. DEEP BRAIN STIMULATION AND INTRACEREBRAL INFECTION: A CASE REPORT AND REVIEW OF THE LITERATURE. NEUROLOGY AND CLINICAL NEUROSCIENCE. 2014;2(5):161-162. SUMMARY: DEEP BRAIN STIMULATION IS A WELL-ESTABLISHED SURGICAL TREATMENT FOR PATIENTS WITH MOVEMENT DISORDERS. ADVERSE EVENTS, SUCH AS HARDWARE INFECTIONS, ARE WELL KNOWN, BUT INTRACEREBRAL INFECTIONS ARE EXTREMELY RARE, AND CAN DEVELOP BOTH SHORTLY AFTER SURGERY AND AFTER SEVERAL MONTHS. WE PRESENT ONE CASE OF INTRACEREBRAL INFECTION AFTER DEEP BRAIN STIMULATION SURGERY, AND A SHORT REVIEW OF THE LITERATURE. REPORTED EVENT: ONE (B)(6) MALE PATIENT UNDERWENT SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE. THE SURGICAL PROCEDURE WAS CARRIED OUT IN ONE SINGLE THEATER SESSION WITHOUT EXTERNALIZING THE ELECTRODES. PROPHYLACTIC ANTIBIOTICS, 2G OF CLOXACILLIN, WERE GIVEN INTRAVENOUSLY AS A SINGLE DOSE. A COMPUTED TOMOGRAPHY SCAN WAS CARRIED OUT 2 DAYS POSTOPERATIVELY FOR CONFIRMED ELECTRODE LOCALIZATION. THERE WERE NO SIGNS OF EDEMA IN THE COMPUTED TOMOGRAPHY IMAGES AND NO OTHER PATHOLOGY WAS SHOWN. THE PATIENT RECOVERED WELL AND WAS DISCHARGED AFTER FOUR DAYS WITHOUT COMPLAINTS. TEN DAYS POSTOPERATIVELY HE WAS ADMITTED TO HOSPITAL DUE TO CONFUSION, FEVER AND AN ELEVATED C-REACTIVE PROTEIN. COMPUTED TOMOGRAPHY AND MAGNETIC RESONANCE IMAGING (MRI) SHOWED EDEMA ALONG THE LEFT IMPLANTED INTRACEREBRAL LEAD. THE REPORTER STATED THAT THE PATIENT HAD AN INTRACEREBRAL INFECTION. THE WHOLE SYSTEM WAS REMOVE D, AND PERIOPERATIVE BACTERIAL CULTURES WERE TAKEN AND SHOWED PROPIONIBACTERIUM ACNES FROM THE ELECTRODE TIP AND BURRHOLE. THE OTHER CULTURES WERE NEGATIVE. THE PATIENT RECOVERED WITH NORMALIZED COGNITIVE FUNCTION AND DECREASING C-REACTIVE PROTEIN WITHIN 1-2 DAYS. TWO DAYS AFTER REMOVAL OF ELECTRODES, MRI SHOWED REMAINING EDEMA ALONG THE ELECTRODE TRACT. AFTER 2 WEEKS, MRI SHOWED NO SIGNS OF INFECTION OR EDEMA. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR 2 WEEKS POSTOPERATIVELY. THE PATIENT WAS SCHEDULED FOR NEW DBS SURGERY 4 MONTHS AFTER THE INITIAL SURGERY. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT FULLY RECOVERED. IT WAS NOTED THAT THE LEADS WERE DISCARDED AFTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243045 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention