BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 24769381 · Received April 2, 2026

    Report

    Report Number
    2182207-2026-00885
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    January 7, 2026
    Report Date
    April 2, 2026
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: GOTTFRIDSSON R, VARKEY E, WOLF A, GATZINSKY K, LILJENCRANTZ J, THÖRN SE, BÖRJESSON M, ARVIDSSON D, ANDRÉLL P. EFFECTS OF SPINAL CORD STIMULATION ON PAIN, PHYSICAL ACTIVITY, AND SELF-EFFICACY AMONG PATIENTS WITH NEUROPATHIC PAIN. PAIN MANAG. 2026 MAR;16(3):185-199. DOI: 10.1080/17581869.2025.2608572. B3 EVENT DATE: PLEASE NOTE THE EVENT DATE IS BASED ON THE ARTICLE'S ONLINE PUBLICATION DATE, AS NO ADDITIONAL DETAILS WERE AVAILABLE IN THE PUBLISHED LITERATURE. D: PLEASE NOTE THAT THE AUTHORS NOTED THAT THEIR STUDY GROUP INCLUDED "DEVICES FROM ABBOTT LABORATORIES, BOSTON SCIENTIFIC, MEDTRONIC, AND NEVRO CORP." HOWEVER, THE MANUFACTURERS FOR EACH REPORTED EVENT WERE NOT AVAILABLE AT THIS TIME. FOLLOW-UP HAS BEEN CONDUCTED TO CONFIRM WHICH, IF ANY, OF THE DEVICES WERE MANUFACTURED BY THE REPORTING MANUFACTURER; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. CONTINUATION OF D10: 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

    REPORTED EVENTS: 8 SERIOUS ADVERSE EVENTS (COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE) GRADES 3¿5) OCCURRED DURING THE 0¿3 MONTH FOLLOW UP PERIOD AND 3 WITHIN 0¿2 WEEKS AFTER IMPLANTATION. EIGHT OF THESE ELEVEN EVENTS WERE ¿DIRECTLY RELATED TO THE SCS (SPINAL CORD STIMULATION) IMPLANTATION OR TREATMENT.¿ THE AUTHORS CLARIFIED THE GRADES ASSIGNED TO ADVERSE EVENTS WERE FROM 1 TO 5, WHERE GRADES 3¿5 CORRESPONDED WITH SERIOUS ADVERSE EVENTS. GRADE 3 ADVERSE EVENTS INCLUDED SEVERE MEDICAL CONDITIONS THAT COULD LEAD TO HOSPITALIZATION OR PROLONGED HOSPITALIZATION, DISABILITY, AND LIMITATIONS IN SELF-CARE BUT WERE NOT LIFE-THREATENING. GRADE 4 ADVERSE EVENTS INCLUDED LIFE-THREATENING EVENTS OR CONDITIONS IN NEED OF IMMEDIATE INTERVENTIONS. GRADE 5 ADVERSE EVENTS WERE EVENTS CAUSING DEATH. WHICH OF THE FOLLOWING EVENTS WERE ASSIGNED TO WHICH GRADE WAS NOT REPORTED, UNLESS OTHERWISE NOTED. THE AUTHORS STATED THAT THE GRADE 3-5 ADVERSE EVENTS INCLUDED VISION LOSS DURING IMPLANTATION, IMPLANT SITE INFECTION LEADING TO IMPLANTABLE NEUROSTIMULATOR (INS) EXPLANT, LEAD MIGRATION, LEAD DYSFUNCTION, LEAD BREAKAGE, AND ALLERGIC REACTIONS. IT WAS FURTHER CLARIFIED THAT 1 PATIENT EXPERIENCED AN EARLY INFECTION THAT REQUIRED DEVICE EXPLANT. 1 PATIENT EXPERIENCED LEAD MIGRATION. 1 PATIENT EXPERIENCED LEAD DYSFUNCTION. 1PATIENT EXPERIENCED LEAD BREAKAGE. 1 PATIENT EXPERIENCED AN ALLERGIC REACTION. PLEASE SEE THE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828258 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

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