BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3635262 · Received February 19, 2014

    Report

    Report Number
    3007566237-2014-00515
    Event Type
    Injury
    Date Received
    February 19, 2014
    Date of Event
    April 1, 2003
    Report Date
    March 1, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    LITERATURE: SCHERER, CHRISTIAN, HENRIK STOUGAARD, AND CLAUS ANDERSEN. "POSSIBLE STABILIZATION OF SPINAL CORD STIMULATION TREATMENT IN REFRACTORY ANGINA PECTORIS BY IMPLANTATION OF A SECOND ELECTRODE: CASE REPORTS." NEUROMODULATION 6.2 (2003): 88-91. PRINT SUMMARY: THE AUTHORS REPORT A REMEDY FOR PATIENTS WITH SCS TREATMENT THAT EXPERIENCE FREQUENT LEAD MIGRATION. IMPLANTATION OF A SECONDARY ELECTRODE STABILIZES BOTH THE PREVIOUS AND NEWLY IMPLANTED LEADS. IN THREE PATIENTS, REPEATED ELECTRODE DISPLACEMENT OCCURED, AND DESPITE THE ATTEMPT TO REPLACE THE ELECTRODE, IT WAS IMPOSSIBLE TO PROVOKE SUFFICIENT PARAESTHESIA IN THE PAIN AREA. PLACEMENT OF A SECONDARY ELECTRODE IN THE EPIDURAL SPACE GOOD AND STABLE STIMULATION WAS ACHIEVED. REPORTED EVENT: ONE (B)(6) FEMALE PATIENT WITH A HISTORY OF ANGINA PECTORIS HAD THE ELECTRODE ARRAY DISPLACED AND REPLACED FIVE MONTHS AFTER IMPLANT. 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
    104976 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention