BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 22208753 · Received June 15, 2025

    Report

    Report Number
    2182207-2025-01561
    Event Type
    Injury
    Date Received
    June 15, 2025
    Report Date
    June 15, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: ROYDS, J. MANAGEMENT AND COST OF SPINAL CORD STIMULATOR EXPLANTS DUE TO INFECTION. NEUROMODULATION: TECHNOL. NEURAL INTERFACE (2025) DOI:10.1016/J.NEUROM.2025.03.069. CONTINUATION OF D10: PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD, UBD: UNKNOWN, UDI#: UNKNOWN. 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: 1. IT WAS REPORTED THAT 23 PATIENTS UNDERWENT DEVICE EXPLANTS THAT WERE ATTRIBUTED TO INFECTION. 22 OF 23 CASES INVOLVED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS). A TOTAL OF 16 OF 23 CASES (70%) MET THE CRITERIA FOR DEEP SURGICAL SITE INFECTION, WHEREAS SEVEN CASES OCCURRED AFTER 90 DAYS. MICROBIOLOGICAL CULTURES CONFIRMED INFECTIONS IN NINE OF 23 CASES (39%). IN FIVE CASES, EXPLANT WAS PERFORMED OWING TO PUS OBSERVED AROUND THE HARDWARE DURING REVISION SURGERY THAT GREW NO BACTERIA AFTER CULTURE. THE MEDIAN TIME TO EXPLANT DUE TO INFECTION WAS 42 DAYS [29¿356]. REIMPLANTATION OF THE NEUROMODULATION DEVICE WAS ATTEMPTED IN 13 OF 23 PATIENTS (57%). SUCCESSFUL REIMPLANT WAS LIMITED AND ACHIEVED IN ONLY EIGHT OF 13 CASES (62%). THE MEDIAN TIME TO REIMPLANTATION WAS 193 DAYS [181¿658] POST-EXPLANT, AND THE REINFECTION RATE IN THOSE WHO WERE REIMPLANTED WAS 30%. ULTIMATELY, A SUCCESSFUL REIMPLANT WAS ACHIEVED IN 35% OF PATIENTS (EIGHT OF 23) AFTER EXPLANT DUE TO SUSPECTED INFECTION. INFECTIONS PRIMARILY OCCURRED AFTER FULL DEVICE IMPLANTATION (12 PATIENTS), FOLLOWED BY THOSE ESTABLISHED DURING SURGERY (5 PATIENTS), RESULTING FROM/AFTER REVISION SURGERIES (3 PATIENTS), IPG REPLACEMENTS (2 PATIENTS), AND ONE CASE POSSIBLY RELATED TO SEEDING AFTER FACET JOINT INJECTIONS SIX WEEKS PREVIOUSLY. THE MEDIAN TIME TO EXPLANT DUE TO INFECTION WAS 42 DAYS [29¿356 DAYS]. AMONG THOSE PATIENTS WITHIN THE SSI CRITERIA OF 90 DAYS (16/23), MOST EXPLANTS OCCURRED BETWEEN 20 AND 47 DAYS. OF THE PATIENTS WHO FULFILLED THE SSI CRITERIA, ALL WOULD BE CLASSIFIED AS HAVING DEEP SURGICAL SITE INFECTION (SSI) ON THE BASIS OF GROSS ANATOMICAL EXAMINATION DURING SURGERY. NOTABLY, SEVEN OF 23 CASES FELL OUTSIDE THE ESTABLISHED TIMEFRAME OF SSI OF 90 DAYS. THE AUTHORS NOTED THAT ALL PATIENTS HAD RECEIVED ANTIBIOTICS BEFORE THE SURGICAL SWAB DURING EXPLANT. ANTIBIOTICS WERE STARTED EMPIRICALLY IN ALL CASES OF SUSPECTED INFECTION APART FROM THE FIVE CASES IN WHICH PUS WAS FOUND AROUND THE IPG DURING REVISION SURGERY. IN THESE FIVE PATIENTS, ANTIBIOTICS WERE ONLY GIVEN BEFORE SURGICAL INCISION PER OUR PROTOCOL. MICROBIOLOGICAL CULTURES CONFIRMED INFECTIONS IN NINE OF 23 CASES. AMONG THE PATIENTS EXPLANTED WITHIN 90 DAYS OF THE LAST OPERATION WHO FULFILLED THE DEEP SSI CRITERIA (N = 16), SEVEN HAD POSITIVE CULTURE RESULTS, WHEREAS NINE SHOWED NO BACTERIAL GROWTH. OF THESE NINE PATIENTS WITH NO BACTERIAL GROWTH, FIVE HAD BEEN ON IV ANTIBIOTICS BEFORE THE EXPLANT. THE OTHER FOUR PATIENTS HAD BEEN ON ORAL ANTIBIOTICS BETWEEN THREE AND SIX DAYS BEFORE EXPLANT. IN THOSE PATIENTS EXPLANTED AFTER 90 DAYS OF THE LAST OPERATION (OUTSIDE THE SSI CRITERIA), FIVE PATIENTS EXHIBITED PUS AROUND THE HARDWARE DURING REVISION SURGERY AND WERE EXPLANTED OWING TO SUSPECTED INFECTION. ANTIBIOTICS WERE ONLY GIVEN PROPHYLACTICALLY FOR SURGERY WITHIN AN HOUR OF SURGICAL INCISION. ALTHOUGH ASYMPTOMATIC FOR INFECTION, ONE OF THESE PATIENTS UNDERWENT IPG REPOSITIONING OWING TO PAIN. THERE WERE NO SUSPICIONS OF INFECTION IN THE REMAINING FOUR CASES, AND NONE OF THESE FIVE CASES GREW BACTERIA ON CULTURE. THREE PATIENTS HAD PUS CELLS PRESENT ON THE MICROBIOLOGY REPORT WITH NO GROWTH ON CULTURE IN THE REMAINING TWO PATIENTS. TWO PATIENTS HAD NORMAL WHITE CELL COUNT WITH C-REACTIVE PROTEIN LEVELS OF 4 MG/L AND 8 MG/L OBTAINED ON THE DAY OF SURGERY; BLOOD SAMPLES WERE NOT TAKEN IN THE REMAINING THREE CASES. NO TISSUE SAMPLES WERE SENT FOR PATHOLOGICAL ASSESSMENT OR HYPERSENSITIVITY IN ANY OF THESE PATIENTS. ONE PATIENT WAS EXPLANTED AFTER ONE YEAR OWING TO AN INFECTED SUPERFICIAL GRANULOMA OVER THE IPG SITE THAT CULTURED S AUREUS. INFECT ION SIGNS DEVELOPED IN ANOTHER 2696 DAYS (7.4 YEARS) AFTER IMPLANTATION, POSSIBLY RELATED TO SEEDING FROM FACET JOINT INJECTIONS SIX WEEKS EARLIER AND CULTURED PSEUDOMONAS. THE AUTHORS NOTED THE SITE(S) OF LOCATION AS 11 PATIENTS AT THE INS, 6 PATIENTS AT THE INS AND LEADS (SAME LOCATION), 5 PATIENTS AT THE INS AND LEADS (SEPARATE LOCATIONS), AND 1 PATIENT AT THE LEAD SITE. REGARDING ADDITIONAL MORBIDITY IN THE ENTIRE COHORT, A SMALL EPIDURAL ABSCESS BECAME APPARENT AFTER EXPLANT IN ONE PATIENT. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS, AND THE EPIDURAL ABSCESS SUBSEQUENTLY RESOLVED ON IMAGING SIX WEEKS LATER WITHOUT FURTHER INTERVENTION. TWO PATIENTS REQUIRED ADDITIONAL SURGERY AFTER EXPLANT. ONE REQUIRED ADDITIONAL SURGERY FOR WOUND REINFECTION, WHEREAS ANOTHER NEEDED THREE ADDITIONAL OPERATIONS WITH THE PLASTIC SURGERY TEAM FOR ONGOING WOUND DEHISCENCE. NO CASES OF PERMANENT NEUROLOGIC DAMAGE, INTENSIVE CARE ADMISSION, OR MORTALITY WERE REPORTED. 2. THREE OF THE PATIENTS WHO WERE REIMPLANTED WERE REINFECTED AND REQUIRED ANOTHER EXPLANT. IN THE THREE PATIENTS WHO WERE REINFECTED, ALL HAD AN AMERICAN SOCIETY OF ANAESTHESIA SCORE OF 2; THERE WERE NO OTHER VARIABLES THAT PROBABLY CONTRIBUTED TO SSI IN TERMS OF PATIENT DEMOGRAPHICS OTHER THAN A HISTORY OF BREAST CANCER IN ONE CASE, BUT THEY WERE NOT ON ANY IMMUNOTHERAPY. TWO OF THESE PATIENTS HAD PERSISTENT SPINAL PAIN SYNDROME (PSPS) TYPE 2 AND THE OTHER, COMPLEX REGIONAL PAIN SYNDROME. ON CULTURE, ONE PATIENT WAS REPORTED AS HAVING ONLY PUS CELLS IN THE ABSENCE OF BACTERIAL GROWTH, WHICH MIMICKED THE MICROBIOLOGY RESULT ON THE INITIAL EXPLANT. AFTER THE SECOND EXPLANT, THE PATIENT WAS TESTED FOR ALLERGIES, YIELDING NEGATIVE RESULTS FOR DEVICE-RELATED ALLERGIES. FURTHER IMPLANTATION WAS NOT PURSUED. THE TWO OTHER PATIENTS HAD S AUREUS CULTURED AND NO GROWTH, AND ONLY ONE OF THESE PATIENTS UNDERWENT A THIRD IMPLANT THAT WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594965 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...."