BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 2551498 · Received April 27, 2012

    Report

    Report Number
    3007566237-2012-00916
    Event Type
    Malfunction
    Date Received
    April 27, 2012
    Date of Event
    June 11, 2011
    Report Date
    April 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE CORRECTION, DEVICES MADE BY DIFFERENT MANUFACTURER.

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD. THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    VALLEJO, R., ZEVALLOS, M., LOWE, J., BENYAMIN, R. IS SPINAL CORD STIMULATION AN EFFECTIVE TREATMENT OPTION FOR DISCOGENIC PAIN? PAIN PRACTICE, 12(3); 2012; 194-201. DOI. 10.1111/J.1533-2500.2011.00489.X SUMMARY: IN A PROSPECTIVE OBSERVATIONAL STUDY CONDUCTED IN AN URBAN PAIN MANAGEMENT CENTER, WE EVALUATED WHETHER SPINAL CORD STIMULATION (SCS) IS EFFECTIVE IN RELIEVING DISCOGENIC PAIN OF IDD ORIGIN. THIRTEEN PATIENTS WITH INTRACTABLE DISCOGENIC LOW BACK PAIN WERE ENROLLED. FOUR PATIENTS NEVER UNDERWENT PERMANENT IMPLANTATION DUE TO INSURANCE DENIAL, MEDICAL REASONS OR FAILED TRIAL AND SERVED AS A CONTROL GROUP. NINE PATIENTS UNDERWENT SCS IMPLANTATION (TREATMENT GROUP). ALL PATIENTS WERE FOLLOWED FOR 12 MONTHS AND ASSESSED AT EACH INTERVAL FOR PAIN (NRS), DISABILITY (ODI), AND OPIOID USE. NINE PATIENTS COMPLETED THE SCS TRIAL WITH > 50% PAIN RELIEF. THE CURRENT STUDY INDICATES THAT SCS MAY PROVIDE EFFECTIVE PAIN RELIEF, IMPROVE DISABILITY, AND REDUCE OPIOID USAGE IN PATIENTS WITH DISCOGENIC PAIN. REPORTED EVENT: ONE PATIENT HAD A MOTOR VEHICLE ACCIDENT WHICH RESULTED IN LEAD MIGRATION. THE PATIENT REFUSED REVISION OF THE STIMULATOR LEADS, AND NO FURTHER DATA WAS COLLECTED FROM THIS PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION SHOWED THE DEVICES USED IN THIS STUDY WERE NOT MADE BY THIS MANUFACTURER. NO FURTHER FOLLOW UP WILL BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEU_INS_STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1