BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 5355343 · Received January 8, 2016

    Report

    Report Number
    3007566237-2016-00156
    Event Type
    Injury
    Date Received
    January 8, 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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 THE MEETING OF THE NORTH AMERICAN NEUROMODULATION SOCIETY AT WHICH THIS ABSTRACT WAS PRESENTED, 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 REPORTED EVENTS WITH ANY 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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    KNEZEVIC, N. N., LISSOUNOV, A., KNEZEVIC, I., KHAMESI, M. T., MOTAHARI, H., CANDIDO, K. D. SMOKING INCREASES THE RISK OF LEAD MIGRATION, BUT DOES NOT INCREASE THE RISK OF INFECTION (10501). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015 SUMMARY: AN IMPACT OF SMOKING IS UNDISPUTED ON GENERAL HEALTH AND PATIENT RECOVERY AFTER SURGICAL PROCEDURES. SMOKERS ARE SHOWN TO BE AT INCREASED RISK FOR INFECTIONS AMONG PERIOPERATIVE PATIENTS. WE EXAMINED THE EFFECTS OF TOBACCO SMOKING ON SCS EFFICACY AND RATES OF COMMON COMPLICATIONS WITH SCS. REPORTED EVENTS: AN UNKNOWN NUMBER OF SPINAL CORD STIMULATION (SCS) PATIENTS EXPERIENCED LEAD MIGRATION; AN UNKNOWN NUMBER OF SCS PATIENTS REQUIRED A REVISION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14437 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention