BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 7865022 · Received September 11, 2018

    Report

    Report Number
    3007566237-2018-02710
    Event Type
    Injury
    Date Received
    September 11, 2018
    Date of Event
    April 3, 2018
    Report Date
    September 11, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE ARTICLE MENTIONED IN THIS REPORTED HAS BEEN PREVIOUSLY. PLEASE SEE REGULATORY REPORT 3007566237-2018-01793. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BARTEK J., JR., SKYRMAN, S., NEKLUDOV, M., MATHIESEN, T., LIND, F., SCHECHTMANN, G. HYPERBARIC OXYGEN THERAPY AS ADJUVANT TREATMENT FOR HARDWARE-RELATED INFECTIONS IN NEUROMODULATION. STEREOTACT FUNCT NEUROSURG. 2018 96(2): 100-107. DOI: 10.1159/000486684. SUMMARY: IN NEUROMODULATION THERAPIES, HARDWARE-RELATED INFECTIONS ARE A MAJOR CHALLENGE OFTEN LEADING TO HARDWARE REMOVAL. TO INVESTIGATE THE ROLE OF ADJUVANT HYPERBARIC OXYGEN THERAPY (HBOT) IN HARDWARE-RELATED INFECTIONS. FOURTEEN HARDWARE-RELATED INFECTION EVENTS IN 12 CONSECUTIVE PATIENTS BETWEEN 2002 AND 2015 WERE TREATED WITH ANTIBIOTICS AND ADJUVANT HBOT AT THE KAROLINSKA UNIVERSITY HOSPITAL ((B)(4)). TWO TIME-INDEPENDENT INFECTION EVENTS RELATED TO HARDWARE REPLACEMENTS OC¬CURRED IN 2 PATIENTS. INFECTION RESOLUTION AND THE NEED FOR HARDWARE REMOVAL WERE ASSESSED. TWELVE OUT OF 14 EVENTS OF HARDWARE-RELATED INFECTION WERE SUCCESSFULLY TREAT¬ED WITHOUT HARDWARE REMOVAL (86%). THE 2 PATIENTS TREATED TWICE WITH HBOT ON 2 TIME-INDEPENDENT OCCASIONS COULD RETAIN THEIR HARDWARE IN BOTH CASES. HARDWARE WAS REMOVED FOLLOWING HBOT FAILURE IN 2 INFECTION EVENTS, WITH LONG-TERM INFECTION CONTROL ACHIEVED IN ALL PATIENTS. FURTHER, AN INTRATHECAL PUMP MALFUNCTION CAUSED BY HBOT AT 2.8 BARS WAS OBSERVED, LEADING TO A CHANGE IN THE MANUFACTURER¿S GUIDELINES. THIS STUDY INDICATES A POTENTIAL BENEFIT OF ADJUVANT HBOT IN THE TREATMENT OF HARDWARE-RELATED INFECTIONS IN NEUROMODULATION, DIMINISHING THE NEED FOR HARDWARE REMOVAL AND TREATMENT INTERRUPTION. PROSPECTIVE STUDIES ARE WARRANTED TO ESTABLISH THE ROLE OF ADJUVANT HBOT IN THE TREATMENT OF HARDWARE-RELATED INFECTIONS IN NEUROMODULATION. REPORTED EVENT: A (B)(6) YEAR-OLD FEMALE PATIENT WITH EPILEPSY EXPERIENCED AND STIMULATION POCKET INFECTION 20 DAYS AFTER IMPLANTATION. THE HARDWARE-RELATED INFECTION EVENT WAS TREATED WITH ADJUVANT HYPERBARIC OXYGEN THE (HBOT). THE PATIENT WAS ON AN ANTIBIOTIC TREATMENT FOR 16 WEEKS AND A WOUND CULTURE NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706554 NEU_INS_STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other| R