BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 5539963 · Received March 31, 2016

    Report

    Report Number
    3007566237-2016-01551
    Event Type
    Injury
    Date Received
    March 31, 2016
    Date of Event
    October 28, 2015
    Report Date
    March 31, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE: THIS VALUE IS THE MEDIAN AGE OF THE PATIENTS IN THE ¿SUBQ ADD-ON¿ (SUBCUTANEOUS + TRADITIONAL SPINAL CORD STIMULATION) COHORT REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS (19 MALE, 9 FEMALE) IN THE ¿SUBQ ADD-ON¿ COHORT REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. EVENT DATE: 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. THE DEVICE WAS USED IN AN OFF-LABEL MANNER. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3877, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 3888, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 3888, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VAN GORP, E.J., TEERNSTRA, O.P., GULTUNA, I., HAMM-FABER, T., BURGER, K., SCHAPENDONK, R., KALLEWAARD, J.W., SPINCEMAILLE, G., VONHOGEN, L.H., HENDRIKS, J.C.M., VISSERS, K.C.P. SUBCUTANEOUS STIMULATION AS ADD-ON THERAPY TO SPINAL CORD STIMULATION IS EFFECTIVE IN TREATING LOW BACK PAIN IN PATIENTS WITH FAILED BACK SURGERY SYNDROME: A MULTICENTER RANDOMIZED CONTROLLED TRIAL. NEUROMODULATION. 2016;19(2):171-178. DOI: 10.1111/NER.12385. SUMMARY: SUPPRESSION OF BACK PAIN WITH TRADITIONAL SPINAL CORD STIMULATION (SCS) IN FAILED BACK SURGERY SYNDROME PATIENTS IS OFTEN INSUFFICIENT. THE OBJECTIVE OF THIS STUDY WAS TO INVESTIGATE THE EFFICACY OF SUBCUTANEOUS STIMULATION (SUBQ) AS ADD-ON THERAPY TO SCS IN TREATING BACK PAIN IN FAILED BACK SURGERY SYNDROME PATIENTS. SUBCUTANEOUS STIMULATION AS AN ADD-ON THERAPY TO SCS IS EFFECTIVE IN TREATING BACK PAIN IN FAILED BACK SURGERY SYNDROME PATIENTS WHERE SCS IS ONLY EFFECTIVE FOR PAIN IN THE LEG. REPORTED EVENTS FOR SUBCUTANEOUS STIM GROUP: 2 PATIENTS WITH COMBINED SPINAL CORD STIMULATION (SCS) AND SUBCUTANEOUS NERVE STIMULATION (SUBQ) FOR LEG/LOW BACK PAIN DUE TO FAI LED BACK SURGERY SYNDROME (FBSS) EXPERIENCED AN INFECTION WHICH REQUIRED SURGERY TO REMOVE THE DEVICE. ONE PATIENT WITH COMBINED SCS AND SUBQ FOR LEG/LOW BACK PAIN DUE TO FBSS EXPERIENCED AN INFECTION WHICH REQUIRED ANTIBIOTICS. ONE PATIENT WITH COMBINED SCS AND SUBQ FOR LEG/LOW BACK PAIN DUE TO FBSS EXPERIENCED SCS LEAD MIGRATION. ONE PATIENT WITH COMBINED SCS AND SUBQ FOR LEG/LOW BACK PAIN DUE TO FBSS EXPERIENCED SUBQ LEAD MIGRATION. ONE PATIENT WITH COMBINED SCS AND SUBQ FOR LEG/LOW BACK PAIN DUE TO FBSS EXPERIENCED SUBQ LEAD "FAILURE." IT WAS NOTED THAT PATIENTS WERE IMPLANTED WITH ONE EPIDURAL LEAD MODEL 3877, AND 1 OR 2 SUBCUTANEOUS LEADS MODEL 3888 DEPENDING ON WHETHER THEIR BACK PAIN WAS UNILATERAL OR BILATERAL. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC PATIENT/DEVICE IDENTIFIERS FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT. FOLLOW-UP TO THE ARTICLE'S CORRESPONDING AUTHOR HAS BEEN REQUESTED FOR ADDITIONAL/MISSING EVENT INFORMATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194071 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention