BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 20191277 · Received September 11, 2024

    Report

    Report Number
    2182207-2024-03844
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    June 20, 2024
    Report Date
    September 11, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: GULISANO, H. A., ERIKSEN, E., BJARKAM, C. R., DREWES, A. M., <(>&<)> OLESEN, S. S. (2024). A SHAM-CONTROLLED, R ANDOMIZED TRIAL OF SPINAL CORD STIMULATION FOR THE TREATMENT OF PAIN IN CHRONIC PANCREATITIS. EUROPEAN JOURNAL OF PAIN, 00, 1¿13. DOI: 10.1002/EJP.2315. A2: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B3: PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S ACCEPTANCE DATE AS SPECIFIC EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B5: IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONTINUATION OF D10: PRODUCT ID NEU_UNKNOWN_LEAD LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 97715 LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_UNKNOWN_LEAD LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: PRODUCT ID: 97715, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: G2: THE COUNTRY OF ORIGIN IS DENMARK. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE SUMMARY: THE AUTHORS PERFORMED A SHAM-CONTROLLED TRIAL TO APPLY HIGH-FREQUENCY (1000 HZ) SPINAL CORD STIMULATION IN PATIENTS WITH VISCERAL PAIN DUE TO CHRONIC PANCREATITIS. THE AUTHORS DID NOT FIND EVIDENCE FOR CLINICALLY RELEVANT PAIN RELIEF. TAKEN TOGETHER WITH POTENTIAL PROCEDURE-RELATED COMPLICATIONS, ADVERSE EFFECTS AND COSTS ASSOCIATED WITH SPINAL CORD STIMULATION, THE AUTHORS FINDINGS QUESTION ITS USE FOR MANAGEMENT OF VISCERAL PAIN. REPORTED EVENTS: 1. ONE PATIENT HAD DIFFICULTY IN CORRECTLY USING THE EQUIPMENT, AND THEREFORE HAD THE INS AND ELECTRODE REMOVED. 2. ONE PATIENT HAD AN ELECTRODE REPLACED WITHIN 12 HOURS OF THE PRIMARY PROCEDURE DUE TO ELECTRODE MIGRATION AND INSUFFICIENT PAIN COVERAGE OF THE PAINFUL AREA. 3. ONE PATIENT HAD "ELECTRODE DYSFUNCTION" REQUIRING SURGICAL REVISION AND REIMPLANTATION. 4. ONE PATIENT HAD AN INFECTION RELATED TO THE INS, REQUIRING SURGICAL REVISION AND REIMPLANTATION. 5. LONG-TERM PAIN RELIEF OF APPROXIMATELY 40% REDUCTION IN PAIN SCORES FROM BASELINE WAS OBSERVED IN THE OPEN-LABEL EXTENSION OF THE STUDY. 6. THE AUTHORS OBSERVED PRESSURE HYPERALGESIA AT THE T10 BACK DERMATOME FOLLOWING BOTH SCS AND SHAM STIMULATION. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538173 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION 97715

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown Required Intervention "SEE H11...."