BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7603980 · Received June 14, 2018

    Report

    Report Number
    3007566237-2018-01790
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    April 3, 2018
    Report Date
    June 14, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#:. 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. DOI: 10.1159/000486684. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    SUMMARY: IN NEUROMODULATION THERAPIES, HARDWARE-RELATED INFECTIONS ARE A MAJOR CHALLENGE OFTEN LEADING TO HARDWARE REMOVAL. OBJECTIVE: TO INVESTIGATE THE ROLE OF ADJUVANT HYPERBARIC OXYGEN THERAPY (HBOT) IN HARDWARE-RELATED INFECTIONS. METHODS: FOURTEEN HARDWARE-RELATED INFECTION EVENTS IN 12 CONSECUTIVE PATIENTS BETWEEN 2002 AND 2015 WERE TREATED WITH ANTIBIOTICS AND ADJUVANT HBOT AT THE (B)(6) HOSPITAL ((B)(6)). TWO TIME-INDEPENDENT INFECTION EVENTS RELATED TO HARDWARE REPLACEMENTS OCCURRED IN 2 PATIENTS. INFECTION RESOLUTION AND THE NEED FOR HARDWARE REMOVAL WERE ASSESSED. RESULTS: TWELVE OUT OF 14 EVENTS OF HARDWARE-RELATED INFECTION WERE SUCCESSFULLY TREATED WITHOUT HARDWARE REMOVAL ((B)(6)%). 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. CONCLUSIONS: 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 EVENTS: PATIENT 7: A (B)(6)-YEAR-OLD MALE PATIENT WITH BILATERAL DBS FOR LESCH-NYHAN SYNDROME REQUIRED EXCHANGE OF BOTH ELECTRODES AND IMPLANTABLE NEUROSTIMULATOR (INS) FOR A NEW SYSTEM IMPLANTATION. THE CAUSE FOR THIS REPLACEMENT WAS NOT PROVIDED. PATIENT 7: A (B)(6)-YEAR-OLD MALE PATIENT WITH BILATERAL DBS FOR LESCH-NYHAN SYNDROME DEVELOPED A UNILATERAL INS POCKET INFECTION 29 DAYS AFTER SYSTEM REPLACEMENT. (B)(6) WAS CULTURED. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR 10 WEEKS AND ALL INFECTIONS WERE ALSO TREATED WITH HBOT WHICH INVOLVED PLACING THE PATIENT IN HYPERBARIC CHAMBERS FOR A NUMBER OF TREATMENTS SITTING IN 100% OXYGEN AND PRESSURIZED TO 2.0-2.8 BAR. THE PATIENTS BREATHED OXYGEN FOR THREE 25-MINUTE PERIODS WHICH WERE INTERRUPTED BY TWO 10-MINUTE AIR BREAKS. A SURGICAL SITE REVISION IN THE FORM OF A WOUND DEBRIDEMENT OR CRUST REMOVAL PROCEDURE WAS PERFORMED, HOWEVER NO DEVICE REMOVAL WAS REQUIRED. THE INFECTION WAS RESOLVED WITHIN 10 WEEKS. PATIENT 7: A (B)(6)-YEAR-OLD MALE PATIENT WITH BILATERAL DBS FOR LESCH-NYHAN SYNDROME DEVELOPED A UNILATERAL INS POCKET INFECTION 10 DAYS AFTER INS EXCHANGE. (B)(6) WAS CULTURED. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR 9 WEEKS AND ALL INFECTIONS WERE ALSO TREATED WITH HBOT WHICH INVOLVED PLACING THE PATIENT IN HYPERBARIC CHAMBERS FOR A NUMBER OF TREATMENTS SITTING IN 100% OXYGEN AND PRESSURIZED TO 2.0-2.8 BAR. THE PATIENTS BREATHED OXYGEN FOR THREE 25-MINUTE PERIODS WHICH WERE INTERRUPTED BY TWO 10-MINUTE AIR BREAKS. NO DEVICE REMOVAL WAS REQUIRED. THE INFECTION WAS RESOLVED WITHIN 9 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446493 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention