BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 5347680 · Received January 6, 2016

    Report

    Report Number
    3007566237-2016-00058
    Event Type
    Injury
    Date Received
    January 6, 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
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ABSTRACT, WHICH IN THIS CASE IS THE FIRST DAY OF THIS MEETING OF THE NORTH AMERICAN NEUROMODULATION SOCIETY, AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). NOTE THE REMOVAL OF PATIENT SYMPTOM CODES SINCE IT WAS DISCOVERED THROUGH FOLLOW-UP THAT THE PATIENT WAS IMPLANTED WITH A NON-MEDTRONIC DEVICE.

    Description of Event or Problem · 1

    BARANIDHARAN, G., RICHERT, G.J., YEARWOOD, T.L. A NOVEL APPROACH TO REDUCE COMPLICATIONS FROM IMPULSE GENERATORS (IPG) IN PATIENTS WITH CHRONIC PAIN (10804). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015. 376. SUMMARY: NEUROMODULATION IS A WELL-ACCEPTED THERAPY FOR CHRONIC PAIN. THE MOST DIFFICULT PART OF THE TECHNIQUE IS ELECTRODE PLACEMENT AND PLACING THE IPG IS RELATIVELY SIMPLE. THEREFORE IT IS ESPECIALLY DISAPPOINTING FOR THE PATIENT/CLINICIAN WHEN IPG RELATED COMPLICATIONS OCCUR. IN THE LEEDS PAIN CLINIC WE HAVE MODIFIED OUR TECHNIQUE FOR IPG POSITIONING USING A NOVEL APPROACH TO PLACE THE IPG OVER THE CHEST WALL RATHER THAN IN THE ABDOMEN/BUTTOCK. WE PRESENT A RETROSPECTIVE AUDIT OF THIS CHANGE IN PRACTICE OVER A 10-MONTH PERIOD. REPORTED EVENTS: ONE CHRONIC PAIN PATIENT EXPERIENCED AN IMPLANTABLE NEUROSTIMULATOR (INS) RELATED COMPLICATION: THEY HAD A LOCALIZED ALLERGIC REACTION TO THE IMPLANT THAT NECESSITATED ITS REMOVAL. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT WAS IMPLANTED WITH A NON-MEDTRONIC DEVICE, AND THAT IT HAD BEEN REPORTED TO THE APPROPRIATE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7844 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention