BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 7605109 · Received June 15, 2018

    Report

    Report Number
    3007566237-2018-01793
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    April 3, 2018
    Report Date
    August 20, 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT. 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. THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN; PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN; PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN; 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.

    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 KAROLINSKA UNIVERSITY HOSPITAL (STOCKHOLM, SWEDEN). 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 (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. 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: 1. PATIENT 5: A (B)(6) MALE PATIENT WITH UNILATERAL DEEP BRAIN STIMULATION (DBS) FOR ESSENTIAL TREMOR (ET) DEVELOPED EROSION AND INFECTION OF THE INS POCKET 6 MONTHS AFTER INS REPLACEMENT. STAPHYLOCOCCUS AUREUS 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. REMOVAL OF THE INS WAS ULTIMATELY REQUIRED, BUT THE INFECTION WAS RESOLVED WITHIN 10 WEEKS. 2. PATIENT 1: A (B)(6) FEMALE PATIENT WITH UNILATERAL DBS FOR ET DEVELOPED AN INFECTION OF THE SCALP INCISION ABOVE THE BURR HOLE 29 DAYS AFTER LEAD IMPLANTATION. STAPHYLOCOCCUS AUREUS WAS CULTURED. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR 16 WEEKS AND ALL INFECTIONS WERE ALSO TREATED WITH HYPERBARIC OXYGEN THERAPY (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 BY 16 WEEKS. 3. PATIENT 2: A (B)(6) MALE PATIENT WITH UNILATERAL DBS FOR ET DEVELOPED AN INFECTION OF THE SCALP WITH EXPOSED HARDWARE AND MUSCULATURE 75 DAYS AFTER LEAD IMPLANTATION. PROPIONIBACTERIUM ACNES WAS CULTURED. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR 12 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 BY 12 WEEKS. 4. PATIENT 3: AN (B)(6) FEMALE PATIENT WITH UNILATERAL DBS FOR ET DEVELOPED AN INFECTION OF THE SCALP WITH EXPOSED HARDWARE AND MUSCULATURE 43 DAYS AFTER IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTATION. STAPHYLOCOCCUS AUREUS WAS CULTURED. THE PATIENT WAS TREAT ED WITH ANTIBIOTICS FOR 60 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 BY 60 WEEKS. 5. PATIENT 3: AN (B)(6) FEMALE PATIENT WITH UNILATERAL DBS FOR ET DEVELOPED AN INFECTION OF THE SCALP WITH EXPOSED HARDWARE/EROSION 24 MONTHS AFTER INS IMPLANTATION. STAPHYLOCOCCUS AUREUS WAS CULTURED. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR 6 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 6 WEEKS. 6. PATIENT 3: AN (B)(6) FEMALE PATIENT WITH UNILATERAL DBS FOR ET DEVELOPED AN INFECTION WITH SKIN EROSION 2 YEARS AFTER THE PREVIOUS PROCEDURE. ALL HARDWARE WAS IMMEDIATELY REMOVED BECAUSE THE NEUROMODULATION THERAPY HAD REPORTEDLY LOST ITS EFFECT BY THAT POINT. 7. PATIENT 4: A (B)(6) MALE PATIENT WITH UNILATERAL DBS FOR ET DEVELOPED AN INFECTION OF THE SCALP WITH EXPOSED HARDWARE 13 DAYS AFTER LEAD IMPLANTATION. ENTEROBACTER AEROGENES WAS CULTURED. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR 6 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 6 WEEKS. 8. PATIENT 6: A (B)(6) MALE PATIENT WITH UNILATERAL DBS FOR ET DEVELOPED EROSION AND INFECTION OF THE SCALP 30 MONTHS AFTER LEAD IMPLANTATION. PROPIONIBACTERIUM ACNES WAS CULTURED. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR 16 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 BY 16 WEEKS. 9. 2 PATIENTS WITH DBS DEVELOPED A NEUROMODULATION RELATED INFECTION THAT WAS TREATED WITH HBOT. THIS 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. IT WAS NOT POSSIBLE TO ASCERTAIN ANY ADDITIONAL SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449411 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7426 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention