BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8755242 · Received July 2, 2019

    Report

    Report Number
    3007566237-2019-01458
    Event Type
    Injury
    Date Received
    July 2, 2019
    Date of Event
    February 11, 2019
    Report Date
    July 2, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. THE REPORTED EVENTS WERE FROM THE FOLLOWING LITERATURE ARTICLE: LEVI V, MESSINA G, FRANZINI A, DI LAURENZIO NE, FRANZINI A, TRINGALI G, RIZZI M. ANTIBIOTICS IMPREGNATED CATHETER COATING TECHNIQUE FOR DEEP BRAIN STIMULATION HARDWARE INFECTION: AN EFFECTIVE METHOD TO AVOID INTRACRANIAL LEAD REMOVAL. OPERATIVE NEUROSURGERY 0:1-8(2019). DOI: 10.1093/ONS.OPZ118. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE FOLLOWING EVENT WAS REPORTED IN LITERATURE: ONE (B)(6) FEMALE WITH UNILATERAL VENTRAL INTERMEDIATE NUCLEUS OF THE THALAMUS (VIM) DEEP BRAIN STIMULATION (DBS) FOR ESSENTIAL TREMOR (ET) EXPERIENCED TYPE II INFECTION OF THE RIGHT LEAD-CABLE JUNCTION 180 DAYS AFTER LEAD PLACEMENT. AFTER PERFORMING A BRAIN COMPUTED TOMOGRAPHY WITH CONTRAST ENHANCEMENT TO RULE OUT BRAIN OR MENINGES INVOLVEMENT, A SUPERFICIAL SWAB WAS OBTAINED, AND THE PATIENT WAS IMMEDIATELY STARTED ON CEFTRIAXONE 2G IV Q 12H AND VANCOMYCIN 15 MG/KG Q 12H FOR TWO WEEKS. ANTIBIOTIC TREATMENT WAS THEN MODIFIED ACCORDING TO THE RESULTS OF THE MICROBIOLOGICAL CULTURE. MICROBIAL CULTURES WERE NEGATIVE. DUE TO THE NON-RESPONSE TO ANTIBIOTIC THERAPY, INCISION, DRAINAGE, AND HARDWARE EXPLORATION WAS PERFORMED. THE RIGHT IMPLANTABLE NEUROSTIMULATOR (INS) AND CABLE WERE REMOVED 16 DAYS LATER, WITH AN ATTEMPT TO SPARE THE INTRACRANIAL LEAD. IT WAS UNCLEAR IF PURULENT DRAINAGE WAS PRESENT IN THIS CASE; HOWEVER, IN CASES OF PURULENT DRAINAGE, THE LEADS WERE DISCONNECTED, AND THE EXTENSIONS AND INS WERE DISCARDED, WHILE LEAD EXTRA-CRANIAL CONTACTS WERE COVERED WITH A PROTECTIVE CAP AND BURIED IN A SUBCUTANEOUS PARIETAL POCKET DISTANT FROM THE SITE OF INFECTION. AFTER HARDWARE REMOVAL, ANTIBIOTIC TREATMENT WAS CONTINUED INTRAVENOUSLY FOR ANOTHER TWO WEEKS. HOWEVER, THE PATIENT PRESENTED CLINICAL AND RADIOLOGICAL SIGNS OF PERSISTENT INFECTION, WHICH LED TO THE COMPLETE HARDWARE REMOVAL. THE FOLLOWING DEVICE SPECIFICS WERE REPORTED: ACTIVA PC IMPLANTABLE NEUROSTIMULATOR; SOLETRA IMPLANTABLE NEUROSTIMULATOR; ACTIVA SC IMPLANTABLE NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546523 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention