BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5345002 · Received January 5, 2016

    Report

    Report Number
    3007566237-2016-00031
    Event Type
    Injury
    Date Received
    January 5, 2016
    Date of Event
    December 10, 2015
    Report Date
    December 12, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION AS IT WAS USED FOR PERIPHERAL NERVE STIMULATION. CONCOMITANT PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    RAOUL, S., NIZARD, J.J.N., LEVESQUE, A. PNS: FIRST FRENCH SERIES OF 80 PATIENTS WITH POSTCHIRURGICAL LOW BACK PAIN (10063). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015. 52. SUMMARY: SUBCUTANEOUS PERIPHERAL NERVE STIMULATION (PNS) IS EFFECTIVE TO TREAT CHRONIC LOW BACK PAIN (LBP). SPINAL CORD STIMULATION COULD BE AN OPTION TO TREAT LBP, BUT DESPITE AN OPTIMAL PLACEMENT OF THE LEAD, LBP COULD BE NOT ACHIEVED IN ALL CASES. THE GOAL OF THIS (B)(6) SERIES OF 80 PATIENTS WAS TO EVALUATE PNS IN LBP. PERIPHERAL NERVE STIMULATION IS EFFECTIVE TO TREAT PATIENTS WITH REFRACTORY CHRONIC LOW BACK PAIN WHO HAVE FAILED WITH CONSERVATIVE MEDICAL TREATMENT. PNS CAN RESCUE FAILURE OF SPINAL STIMULATION ALONE. SIGNIFICANT IMPROVEMENTS IN MANY ASPECTS OF PAIN WERE IMPROVED, AND SIDE EFFECTS WERE MINIMAL. REPORTED EVENTS: 1. 5 PATIENTS WITH INTRACTABLE CHRONIC LOW BACK PAIN TREATED WITH PERIPHERAL NERVE STIMULATION (PNS) EXPERIENCED INFECTIONS OF THE SYSTEM. 2. 5 PATIENTS WITH INTRACTABLE CHRONIC LOW BACK PAIN TREATED WITH PNS EXPERIENCED MIGRATIONS OF THE ELECTRODE. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. 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
    4836 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 Required Intervention