BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_ENS_STIMULATOR

    MDR report key: 2551412 · Received April 27, 2012

    Report

    Report Number
    3007566237-2012-00913
    Event Type
    Injury
    Date Received
    April 27, 2012
    Date of Event
    June 11, 2011
    Report Date
    April 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD LOT# SERIAL# UNKNOWN, IMPLANTED: EXPLANTED: PRODUCT TYP LEAD. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    NOTE CORRECTION, DEVICES NOT MADE BY THIS MANUFACTURER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE AUTHOR OF THE ARTICLE SHOWED THE DEVICES USED IN THE STUDY WERE NOT MANUFACTURED BY THIS COMPANY. NO FURTHER FOLLOW UP WILL BE CONDUCTED.

    Description of Event or Problem · 1

    LITERATURE: 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 (B)(4) 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: PATIENT EXPERIENCED A "WET-TAP" DURING TRIAL LEAD INSERTION. THE PROCEDURE WAS CANCELLED, AND THE PATIENT DID NOT PARTICIPATE IN THE STUDY. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention