BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3120818 · Received May 20, 2013

    Report

    Report Number
    3007566237-2013-01683
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    January 3, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    PATIL, A. A., OTTO, D., RAIKAR, S. PERIPHERAL NERVE FIELD STIMULATION FOR SACROILIAC JOINT PAIN. NEUROMODULATION : JOURNAL OF THE IN TERNATIONAL NEUROMODULATION SOCIETY. 2013. DOI: 10.1111/NER.12030. SUMMARY: THIS STUDY LOOKED RETROSPECTIVELY AT TEN PATIENTS WHO UNDERWENT PNS COMPLETE SYSTEMIMPLANTATION FOR TREATMENT OF SI JOINT PAIN AND HAVE AT LEAST ONE-YEAR FOLLOW-UP. THE AGES RANGED FROM 44 TO 92 YEARS, WITH MEDIAN OF 72.5 YEARS. FOUR PATIENTS WERE FEMALE AND SIX WERE MALE. PATIENTS PRESENTED IN THIS PAPER HAVE A FOLLOW-UP OF 14¿29 MONTHS, WITH A MEDIAN OF 24 MONTHS. PNFS IMPLANT FOR SI JOINT PAIN IS A SIMPLE AND MINIMALLY INVASIVE PROCEDURE TO TREAT CHRONIC DISABLING SI JOINT PAIN. THOUGH THE NUMBER OF PATIENTS IN THIS SERIES IS SMALL AND THE FOLLOW-UP IS RELATIVELY SHORT TO DRAW ANY CONCLUSION, THE RESULT OF THE PRESENT SERIES IS ENCOURAGING. EIGHTY PERCENT OF THE PATIENTS BENEFITED FROM THE PROCEDURE AND 60% HAVE SIGNIFICANT IMPROVEMENT. BY THE VERY NATURE OF THE PROCEDURE, THE LIKELIHOOD OF SERIOUS COMPLICATION IS NEGLIGIBLE. REPORTED EVENT: A PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR FLIPPED WHICH HAD TO BE SURGICALLY CORRECTED. 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
    221936 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention