BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 21698584 · Received March 26, 2025

    Report

    Report Number
    2182207-2025-00814
    Event Type
    Injury
    Date Received
    March 26, 2025
    Report Date
    April 29, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL LITERATURE CITATION: HAMM-FABER, T. ET AL. FEASIBILITY OF COLLECTING OBJECTIVE DATA AND EXPLORING PATIENT¿S EXPERIENCES ON PHYSICAL ACTIVITY IN PERSISTENT SPINAL PAIN SYNDROME TYPE 2 PATIENTS RECEIVING SPINAL CORD STIMULATION: A MIXED FEASIBILITY STUDY. PAIN PR. 25, E70013 (2025). 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.

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: HAMM-FABER TE, VISSERS KCP, BRONKHORST E, ARNTS I, GÜLTUNA I, VAN HAREN FGAM, WENSING CAGL, ENGELS Y, HENSSEN DJHA. IS THERE A CORRELATION BETWEEN OBJECTIVE MEASUREMENT TOOLS AND SELF-REPORTING QUESTIONNAIRES TO EVALUATE PHYSICAL ACTIVITY AND HEALTH STATUS IN PATIENTS WITH PERSISTENT SPINAL PAIN SYNDROME TYPE 2 BEFORE AND AFTER SPINAL CORD STIMULATION? OUTCOMES OF A FEASIBILITY STUDY. NEUROMODULATION. 2025 FEB 15:S1094-7159(25)00020-0. DOI: 10.1016/J.NEUROM.2025.01.007. EPUB AHEAD OF PRINT. PMID: 39955666. 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_EXT LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE EXTENSION 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_EXT, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: G2: THE COUNTRY OF ORIGIN IS THE NETHERLANDS. 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

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE PREVIOUSLY REPORTED TWO INFECTION CASES. IT WAS STATED THAT THE "TWO PATIENTS DEVELOPED AN INFECTION DURING THE TRIAL PERIOD; ONE WAS HOSPITALIZED AND RECEIVED INTRAVENOUS ANTIBIOTICS, AND THE OTHER RECEIVED ORAL ANTIBIOTICS." THE AUTHORS AGAIN NOTED THAT "BOTH PATIENTS FULLY RECOVERED AND HAD NO RESIDUAL SYMPTOMS." NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 0

    LITERATURE SUMMARY: THE EFFECT OF SPINAL CORD STIMULATION (SCS) ON PHYSICAL ACTIVITY IN PATIENTS WITH PERSISTENT SPINAL PAIN SYNDROME (PSPS) TYPE 2 IS COMMONLY EVALUATED WITH STANDARDIZED, VALIDATED SELF-REPORTING QUESTIONNAIRES. HOWEVER, QUESTIONNAIRES ARE SUSCEPTIBLE TO SUBJECTIVE BIAS AND MAY NOT ALIGN WITH OBJECTIVE DATA. THE AUTHORS INVESTIGATED THE CORRELATION AMONG OBJECTIVE MEASUREMENT DEVICES, THE OSWESTRY DISABILITY INDEX (ODI), AND PATIENT¿S HEALTH STATUS REGARDING PHYSICAL ACTIVITY IN PATIENTS WITH PSPS TYPE 2 RECEIVING SCS. ALONGSIDE THE ODI, THE AUTHORS USED AN ACTIVITY TRACKER TO OBJECTIVELY MEASURE PHYSICAL ACTIVITY AND A NEUROSTIMULATOR DEVICE TO OBJECTIVELY MEASURE BODY POSITIONS AT BASELINE AND THREE-MONTH FOLLOW-UP. IN ADDITION, HEALTH STATUS WAS MEASURED USING THE POSITIVE MODEL OF HEALTH. THE AUTHORS INCLUDED 20 PATIENTS, OF WHOM 17 COMPLETED THE THREE-MONTH FOLLOW-UP PERIOD. AT THREE MONTHS FOLLOW-UP, THEY FOUND A SIGNIFICANT CORRELATION BETWEEN THE ACTIVITY TRACKER¿S STEPS (R = -0.636, P = 0.006) AND DISTANCE PER DAY (R = -0.649, P = 0.005) WITH THE ODI AND A SIGNIFICANT CORRELATION OF THE NEUROSTIMULATOR¿S MOBILE POSITION WITH THE ODI (R = -0.497, P = 0.043). FURTHERMORE, THE ACTIVITY TRACKER SHOWED A SIGNIFICANT INCREASE IN STRENUOUS PHYSICAL ACTIVITY AT THREE-MONTH FOLLOW-UP (P = 0.039). THE AUTHORS ALSO OBSERVED A SUBSTANTIAL IMPROVEMENT ACROSS THE DOMAINS OF BODILY FUNCTION, SOCIAL AND SOCIETAL PARTICIPATION, AND DAILY FUNCTIONING OF THE POSITIVE MODEL OF HEALTH. THIS STUDY SHOWED SIGNIFICANT CORRELATIONS AMONG OBJECTIVE MEASUREMENT DEVICES, THE ODI, AND HEALTH STATUS, WHICH COULD CONTRIBUTE TO A MORE HOLISTIC APPROACH. REPORTED EVENTS: 1. IN TWO PATIENTS, AN INFECTION DEVELOPED DURING THE TRIAL PERIOD, STARTING AT THE EXTENSION¿S ENTRY LOCATION WITH THE SKIN ON THE RIGHT FLANK. THE SYSTEM/LEAD WAS REMOVED, AND THE TWO PATIENTS WERE TREATED WITH ANTIBIOTICS, LEADING TO A FULL RECOVERY WITH NO RESIDUAL SYMPTOMS. THE MICROBIOLOGIST ADVISED THE ANTIBIOTICS AND TOGETHER WITH THE HOSPITAL HYGIENIST, CONDUCTED A COMPREHENSIVE REVIEW OF THE REASON FOR THESE INFECTIONS. HOWEVER, THEY FOUND NO SPECIFIC REASON AND MENTIONED THIS AS A COINCIDENCE. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066709 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R "SEE H11...."