BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3576896 · Received January 15, 2014

    Report

    Report Number
    3007566237-2014-00197
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    October 1, 2004
    Report Date
    February 29, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    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_INS_STIMULATOR, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    LITERATURE: RAPHAEL, J.H., SOUTHALL, J.L., GNANADURAI, T.V., TREHARNE, G.J., KITAS, G.D., MULTIPLE LEAD SPINAL CORD STIMULATION FOR CHRONIC MECHANICAL LOW BACK PAIN: A COMPARATIVE STUDY WITH INTRATHECAL OPIOD DRUG DELIVERY. NEUROMODULATION, VOLUME 7, NUMBER 4 (2004). SUMMARY: THE OBJECTIVE OF THIS PAPER IS TO ASSESS THE OUTCOME OF IMPLANTED MULTIPLE THORACOLUMBAR LEAD SPINAL CORD STIMULATION (SCS) IN MECHANICAL BACK PAIN WITHOUT PRIOR SPINAL SURGERY. THESE RESULTS ARE COMPARED WITH INTRATHECAL OPIOID DRUG DELIVERY (ITDD). AN ANONYMOUS THIRD PARTY PATIENT QUESTIONNAIRE STUDY OF PAIN RELIEF, FUNCTION AND PSYCHOSOCIAL QUALITY OF LIFE MEASURES (RECORDED ON 11-POINT NUMERICAL RATING SCALES) FOR 12 PATIENTS WITH SCS AND 13 WITH ITDD WAS USED. EVENTS REPORTED: ONE OF THE SCS PATIENT¿S REQUIRED REVISION SURGERY FOR LEAD MIGRATION. UNKNOWN NUMBER OF SCS PATIENTS REPORTED THAT THEY WERE UNSATISFIED. 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
    40134 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention