BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8755085 · Received July 2, 2019

    Report

    Report Number
    3007566237-2019-01457
    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. PROCODE, PMA/510K #: PLEASE NOTE THAT THIS DEVICE WAS USED IN AN OFF-LABEL MANNER AS IT WAS IMPLANTED FOR TREATMENT OF CHRONIC CLUSTER HEADACHE. 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 PATIENT WITH UNILATERAL POSTERIOR HYPOTHALAMUS (PHYP) DEEP BRAIN STIMULATION (DBS) FOR CHRONIC CLUSTER HEADACHE (HCC) EXPERIENCED A TYPE II INFECTION THE LEFT LEAD-CABLE JUNCTION 150 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 SHOWED (B)(6). DUE TO THE NON-RESPONSE TO ANTIBIOTIC THERAPY, INCISION, DRAINAGE, AND HARDWARE EXPLORATION WAS PERFORMED. THE LEFT IMPLANTABLE NEUROSTIMULATOR (INS) AND CABLE WERE REMOVED 17 DAYS LATER, WITH AN ATTEMPT TO SPARE THE INTRACRANIAL LEAD. THE DISTAL END OF THE LEAD WAS ENVELOPED WITH A SHORT SEGMENT (APPROXIMATELY 4CM LONG) OF ANTIBIOTIC-IMPREGNATED VENTRICULAR CATHETER CONTAINING CLINDAMYCIN AND RIFAMPIN. SUTURES WERE USED TO CLOSE OFF THE PROXIMAL END OF THE CATHETER IN ORDER TO ANCHOR IT TO THE LEAD. AFTER HARDWARE REMOVAL, ANTIBIOTIC TREATMENT WAS CONTINUED INTRAVENOUSLY FOR ANOTHER TWO WEEKS. AT THE SIX-MONTH FOLLOW-UP, THE PATIENT UNDERWENT SUCCESSFUL REIMPLANTATION OF THE EXTENSION AND INS, WHICH WERE CONNECTED TO THE SALVAGED LEAD. NO FURTHER INFECTIVE OR HARDWARE-RELATED COMPLICATIONS WERE NOTICED DURING THE LONG-TERM FOLLOW-UP. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: SOLETRA IMPLANTABLE NEUROSTIMULATOR; ACTIVA SC IMPLANTABLE NEUROSTIMULATOR; ACTIVA PC IMPLANTABLE NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546489 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention