BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 7900052 · Received September 21, 2018

    Report

    Report Number
    3007566237-2018-02846
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    April 16, 2018
    Report Date
    September 21, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR , LOT# UNKNOWN, UNKNOWN SERIAL#, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    NISSEN, M., IKAHEIMO, T. M., HUTTUNEN, J., LEINONEN, V., VON UND ZU FRAUNBERG, M. LONG-TERM OUTCOME OF SPINAL CORD STIMULATION IN FAILED BACK SURGERY SYNDROME: 20 YEARS OF EXPERIENCE WITH 224 CONSECUTIVE PATIENTS. NEUROSURGERY. 2018. 0: 1-8. DOI: 10.1093/NEUROS/NYY194 SUMMARY: FAILED BACK SURGERY SYNDROME (FBSS) IS A CHALLENGING CONDITION THAT LACKS A CURATIVE TREATMENT. IN SELECTED PATIENTS, SPINAL CORD STIMULATION (SCS) HAS PROVIDED A SATISFACTORY OUTCOME. TO EVALUATE THE LONG-TERM OUTCOME OF SCS IN FBSS, AS MEASURED BY (1) THE EXPLANTATION RATE, (2) COMPLICATIONS, AND (3) PATIENT SATISFACTION WITH THE GLOBAL PERCEIVED EFFECT (GPE). METHODS: WE STUDIED 224 CONSECUTIVE FBSS PATIENTS WHO UNDERWENT AN SCS TRIAL WITH SURGICALLY IMPLANTED LEADS AT OUR HOSPITAL BETWEEN JANUARY 1996 AND DECEMBER 2014. THE PATIENTS¿ SATISFACTION WITH THE GPE OF TREATMENT WAS MEASURED THROUGH A POSTAL QUESTIONNAIRE AT THE END OF FOLLOW-UP. BASED ON A 1-WK TRIAL, PERMANENT SCS WAS IMPLANTED IN 175 (78%) PATIENTS. OUT OF THESE PATIENTS, 153 (87%) REPORTED SATISFACTORY OUTCOMES AFTER 2 MO. DURING THE MEAN FOLLOW-UP OF 6 YR, 34 (19%) OF SCS DEVICES WERE PERMANENTLY EXPLANTED DUE TO INADEQUATE PAIN RELIEF, AND 11 (6%) WERE EXPLANTED FOR OTHER REASONS. ELECTRODE REVISION DUE TO INADEQUATE PAIN RELIEF WAS DONE FOR 22 PATIENTS. IN TOTAL, 26 COMPLICATIONS WERE REPORTED DUE TO: 7 DEEP INFECTIONS, 11 HARDWARE MALFUNCTIONS, 1 SUBCUTANEOUS HEMATOMA, 4 INSTANCES OF DISCOMFORT DUE TO THE PULSE GENERATOR, AND 3 ELECTRODE MIGRATIONS. ONE HUNDRED THIRTY PATIENTS (74%) CONTINUED WITH SCS UNTIL THE END OF FOLLOW-UP. OF THEM, 61 (47%) RETURNED THE QUESTIONNAIRE, AND 42 (69%) REPORTED SUBSTANTIALLY IMPROVED OR BETTER GPE. SCS CAN PROVIDE A GOOD OUTCOME IN THE TREATMENT OF FBSS. PATIENT SELECTION COULD BE FURTHER IMPROVED BY DEVELOPING NOVEL PREDICTIVE BIOMARKERS. REPORTED EVENTS: 1. AT THE MEAN FOLLOW-UP OF 6 YR (RANGE 0-18, TOTAL 1395 FOLLOWUP YEARS), 34 SCS DEVICES WERE EXPLANTED DUE TO INEFFICIENT PAIN RELIEF. 2. 22 REVISIONS WERE DONE DUE TO IPG BATTERY DEPLETION (20 PATIENTS). THE MEDIAN BATTERY DURATION WAS 5.5 YR (RANGE 1-10). IN 1 CASE, AFTER IPG DEPLETION, THE WHOLE SCS DEVICE WAS REPLACED WITH A NEW TYPE OF ELECTRODE WITHOUT A TRIAL. 3. 3 PATIENTS EXPERIENCED A REVISION DUE TO IPG REGION DISCOMFORT. 4. AT THE MEAN FOLLOW-UP OF 6 YR (RANGE 0-18, TOTAL 1395 FOLLOWUP YEARS), ONE SCS DEVICE WAS EXPLANTED DUE TO AN UNSUCCESSFUL IMPLANTATION. 5. DUE TO INADEQUATE PAIN RELIEF, 22 REVISIONS WERE DONE TO 19 (11%) PATIENTS, OF WHICH 15 WERE ELECTRODE REPOSITIONINGS. SCS DEVICES WERE LATER EXPLANTED IN 7 OF THESE PATIENTS. 6. 26 REVISIONS WERE COMPLETED DUE TO COMPLICATIONS IN 25 (14%) PATIENTS. 7. THE OVERALL INFECTION RATE, INCLUDING THE TRIAL, WAS 3.1%. ALL OF THE DEEP INFECTIONS WERE POSITIVE FOR BACTERIAL CULTURE (STAPHYLOCOCCUS AUREUS IN SIX PATIENTS AND ACINETOBACTER BAUMANNII IN 1 PATIENT. DEEP INFECTION 1 6 ALL REVISIONS WERE SHORT-TIME EXPLANTATIONS. INFECTION OCCURRED IN 2 PATIENTS DURING THE TRIAL PERIOD, IN 2 PATIENTS AFTER PRIMARY IPG IMPLANTATION, AND IN 2 PATIENTS AFTER ELECTRODE REVISION. ALL PATIENTS GOT A NEW DEVICE LATER WITHOUT A TRIAL. 12. HARDWARE MALFUNCTION 0 11 EXTENSION LEADS WERE REPLACED IN 4 PATIENTS. THE ELECTRODE WAS REPLACED IN 3 PATIENTS. THE IPG WAS REPLACED ONCE IN 1 PATIENT AND IN 1 PATIENT TWICE. THE WHOLE SCS DEVICE WAS REMOVED AND LATER REIMPLANTED IN 1 PATIENT. 8. A SUBCUTANEOUS HEMATOMA WAS EVACUATED AND THE PATIENT EXPERIENCED A REVISION. NO SPECIFIC DEVICE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741215 NEU_INS_STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R