BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5345361 · Received January 5, 2016

    Report

    Report Number
    3007566237-2016-00041
    Event Type
    Injury
    Date Received
    January 5, 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
    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 INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    HOELZER, B., BENDEL, M. A., DEER, T.R., QU, W., MOESCHLER, S., FALOWSKI, S., WASSEF, C., KIM, C., BOWMAN, R., CHOI, D., CHOI, D.Y., CHOE, D., KIM, E., LERMAN, I., MORA, R., WANG, Z., HAYEK, S.M., HANES, M.,ADE, T., NEUMAN, S.A. INFECTION RATES OF SPINAL CORD STIMULATOR IMPLANTS AMONG HIGH RISK POPULATIONS: A MULTI-CENTER STUDY (10301). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015. 107 SUMMARY: INFECTIONS INVOLVING SPINAL CORD STIMULATORS (SCS) OFTEN RESULT IN THE LOSS OF THERAPY AND SUBSTANTIAL ADDED COST TO THE HEALTHCARE SYSTEM. PUBLISHED DATA IN MEDICAL LITERATURE ESTIMATES INFECTION RATES OF SCS IMPLANTATION BETWEEN 3% AND 6%. A REVIEW OF OTHER SURGICAL SPECIALTIES REVEALS THAT THERE ARE PATIENT, ENVIRONMENTAL, AND PROCEDURALIST FACTORS THAT ALL CONTRIBUTE TO POSTOPERATIVE SURGICAL SITE INFECTION RATES; HOWEVER, THERE HAVE NOT BEEN PUBLISHED STUDIES APPROPRIATELY POWERED TO ASSESS THESE FACTORS IN THE SCS POPULATION. OUR MULTI-CENTERED, INCLUDING ACADEMIC AND PRIVATE PRACTICE IMPLANTERS, STUDY AIMS TO ESTABLISH A TRUE RATE OF INFECTION FOR MODERN SCS IMPLANTS. IN ADDITION, WE LOOK AT PRE-EXISTING CONDITIONS THAT MAY IMPACT SCS-RELATED INFECTION RATES. REPORTED EVENTS: OF 1391 IMPLANTS REVIEWED, THERE WERE 33 INFECTIONS REPORTED. IT WAS NOTED THAT REVISION SURGERY WAS SIGNIFICANTLY ASSOCIATED WITH INFECTION. 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
    4524 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 Required Intervention