BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5783997 · Received July 11, 2016

    Report

    Report Number
    3007566237-2016-02586
    Event Type
    Injury
    Date Received
    July 11, 2016
    Date of Event
    March 11, 2016
    Report Date
    July 11, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT AGE: PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE "FAILURE" GROUP IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. PT SEX: PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE "FAILURE" GROUP IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. CONCOMITANT MEDICAL PRODUCTS: LEAD MODEL 39565, LEAD MODEL 3587A, OCTAD LEADS MODEL 3777 (2 PATIENTS); RESUME LEAD; LEAD MODEL 565. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    STRAUSS, I., TAHA, K., KRISHNA, V., HODAIE, M. YOUNGER AGE PREDICTS GREATER EFFECTIVENESS OF SPINAL CORD STIMULATION FOR CHRONIC PAIN. ACTA NEUROCHIRURGICA. 2016; 158(5) 999-1003. DOI: 10.1007/S00701-016-2753-0 SUMMARY: SPINAL CORD STIMULATION (SCS) IS AN ACCEPTED SURGICAL TREATMENT FOR NEUROPATHIC PAIN IN FAILED BACK SYNDROME OR COMPLEX REGIONAL PAIN SYNDROME. HOWEVER, EVEN IN THE BEST SELECTED SURGICAL CASES THE PREDICTORS OF ADEQUATE PAIN CONTROL ARE NOT WELL DEFINED. THE AIM OF THIS STUDY WAS TO IDENTIFY PREDICTORS OF OUTCOME IN PATIENTS WHO UNDERWENT SCS IN OUR CENTER. WE PERFORMED A RETROSPECTIVE ANALYSIS OF OUR NEUROSURGICAL DATABASE FOR PATIENTS WHO UNDERWENT SCS OVER THE LAST 8 YEARS IN AN ATTEMPT TO IDENTIFY FACTORS PREDICTIVE OF OUTCOME. RESULTS FORTY-ONE PATIENTS UNDERWENT IMPLANTATION OF EPIDURAL ELECTRODES, 34 PATIENTS HAD A SUCCESSFUL STIMULATION TRIAL AND RECEIVED PERMANENT DEVICES. NINE PATIENTS EXPERIENCED A LATE FAILURE AT A MEDIAN TIME OF 7.8 MONTHS (RANGE, 4.5¿19 MONTHS) AFTER IMPLANTATION. AGE WAS SIGNIFICANTLY ASSOCIATED WITH OUTCOME. YOUNGER PATIENTS HAD A SIGNIFICANTLY LOWER RATE OF TREATMENT FAILURE, AND NONE OF THE PATIENTS ABOVE 65 YEARS HAD A SUCCESSFUL LONG-TERM OUTCOME. OUR RESULTS SUGGEST THAT YOUNGER AGE IS ASSOCIATED WITH GREATER LONG-TERM EFFECTIVENESS OF SPINAL CORD STIMULATION AND THEREFORE AGE MAY INFLUENCE THE SUCCESS OF SCS THERAPY WITH OLDER PATIENTS HAVING A GREATER TENDENCY TO FAILURE. EARLIER INTERVENTION MAY BE BENEFICIAL IN THESE CHRONIC PAIN PATIENTS. REPORTED EVENT: 5 PATIENTS EXPERIENCED A LATE FAILURE AFTER UNDERGOING SPINAL CORD STIMULATION (SCS) IMPLANT FOR NEUROPATHIC PAIN. LATE FAILURE WAS DEFINED AS LOSS OF BENEFIT FROM STIMULATION AND STOPPING USE OF THE SCS AT THE LAST FOLLOW-UP. REASONS FOR FAILURE WERE BOTHERSOME PARESTHESIA AND/OR NO BENEFIT FROM STIMULATION. THE SYSTEM WAS EXPLANTED UPON REQUEST BY THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437422 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention