BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4346795 · Received December 19, 2014

    Report

    Report Number
    3007566237-2014-03708
    Event Type
    Injury
    Date Received
    December 19, 2014
    Report Date
    November 23, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT MANY OF THE EVENTS IN THE ARTICLE INVOLVED A DIFFERENT MANUFACTURER'S DEVICES AND ALL ADVERSE EVENTS HAD BEEN PREVIOUSLY REPORTED. IT WAS UNCLEAR WHICH EVENTS WERE NOT ASSOCIATED WITH THIS MANUFACTURER'S DEVICES.

    Description of Event or Problem · 1

    MOESCHLER, S.M., SANDERS, R.A., HOOTEN, W.M., HOELZER, B.C. SPINAL CORD STIMULATOR EXPLANTATION FOR MAGNETIC RESONANCE IMAGING: A CASE SERIES. NEUROMODULATION : JOURNAL OF THE INTERNATIONAL NEUROMODULATION SOCIETY. 2014. DOI: 10.1111/NER.12254. SUMMARY: SPINAL CORD STIMULATOR (SCS) SYSTEMS ARE IMPLANTED TO TREAT PAIN CONDITIONS SUCH AS NEUROPATHIC, RADICULAR, AND ISCHEMIC PAIN SYNDROMES. PRIOR TO (B)(6) 2013, SCS SYSTEMS WERE NOT MAGNETIC RESONANCE IMAGING (MRI) COMPATIBLE DUE TO THE RISK OF THERMAL INJURY AT THE SITE OF THE LEADS AND GENERATOR. ALTHOUGH THERE ARE SOME CASE REPORTS OF PATIENTS UNDERGOING MRI STUDIES WITH SCS SYSTEMS IN PLACE, THESE STIMULATORS ARE FREQUENTLY EXPLANTED WHEN CLINICAL CARE HAS NECESSITATED AN MRI. THE PURPOSE OF THIS CASE SERIES IS TO DISCUSS THE ROLE OF SCS EXPLANTATION IN ORDER TO ACQUIRE AN MRI. THIS STUDY WAS PERFORMED AT A TERTIARY ACADEMIC PAIN MEDICINE CLINIC. AFTER EXEMPT STATUS WAS OBTAINED VIA THE INSTITUTIONAL REVIEW BOARD, PATIENTS WERE IDENTIFIED VIA THE USE OF COMMON PROCEDURAL TERMINOLOGY CODES FOR IMPLANTABLE DEVICES. A CHART REVIEW WAS PERFORMED TO IDENTIFY ALL PATIENTS >18 YEARS OF AGE WHO HAD A LUMBAR OR THORACIC DORSAL COLUMN SCS IMPLANTED DURING JANUARY 2001¿DECEMBER 2011. THE CHARTS WERE THEN FOLLOWED TO IDENTIFY ANY PATIENTS WHO UNDERWENT A SURGERY FOR EXPLANTATION OF THE DEVICE. DATA COLLECTION INCLUDED THE TOTAL NUMBER OF PATIENTS UNDERGOING PERMANENT SC S IMPLANTATION, THE TOTAL NUMBER OF EXPLANTATION OF THESE DEVICES, PATIENT DEMOGRAPHIC FACTORS, INDICATION FOR SCS IMPLANTATION, INCIDENCE OF REVISIONS AND THE INDICATION, DURATION BETWEEN IMPLANTATION AND EXPLANT OF THE DEVICE, AND INDICATION FOR EXPLANTATION. DURING THE TIME BETWEEN 2001 AND 2011, 199 PATIENTS WERE IDENTIFIED WHO UNDERWENT A THORACIC OR LUMBAR SCS IMPLANT AFTER A SUCCESSFUL TRIAL. AMONG 199 IMPLANTS, 33 DEVICES WERE EXPLANTED, AND OF THESE, FOUR WERE EXPLANTED DUE TO THE PRIMARY NEED FOR AN MRI SCAN. REPORTED EVENT: ONE (B)(6) FEMALE PATIENT WITH SPINAL CORD STIMULATION (SCS) FOR FAILED BACK SURGERY SYNDROME HAD THE DEVICE EXPLANTED IN 2006, 9 MONTHS AFTER IMPLANT, DUE TO NO PAIN RELIEF DESPITE ADEQUATE COVERAGE. 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
    836030 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 00053 YR Required Intervention