BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR FOR SCS

    MDR report key: 6093365 · Received November 10, 2016

    Report

    Report Number
    3007566237-2016-04016
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    September 16, 2016
    Report Date
    November 10, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S PUBLICATION DATE AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS 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. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    RUBINO, S., ADEPOJU, A., KUMAR, V., PRUSIK, J., MURPHY, N., OWUSU-SARPONG, S., PILITSIS, J.G. MRI CONDITIONALITY IN PATIENTS WITH SPINAL CORD STIMULATION DEVICES. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY. 2016. 94(4):254-258. DOI: 10.1159/000448764 SUMMARY: WE PROVIDE A REVIEW OF THE CLINICAL EXPERIENCE WITH MRI AND SPINAL CORD STIMULATION (SCS) DEVICES AND DEVELOP A GENERAL REFERENCE OF CURRENT DEVICE/MRI SPECIFICATIONS. REPORTED EVENT: IT WAS REPORTED THAT A PATIENT (PATIENT 1) WAS UNABLE TO UNDERGO LUMBAR MRI IMAGING DESPITE BEING IMPLANTED WITH A MRI CONDITIONAL LEAD, DUE TO THE "QUESTION OF INFECTION AT THE LEAD SITE." IT WAS NOTED THE CONDITION WAS A CONTRAINDICATION FOR LUMBAR IMAGING. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744574 IMPLANTABLE NEUROSTIMULATOR FOR SCS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other