BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 11599990 · Received March 31, 2021

    Report

    Report Number
    3006630150-2021-01318
    Event Type
    Injury
    Date Received
    March 31, 2021
    Date of Event
    March 10, 2021
    Report Date
    March 31, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797821
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: (B)(4). MODEL: SC-2316-70. SERIAL: (B)(4). BATCH: 5061250.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO MIGRATION OF ONE OF THE TWO LEADS. IMAGING WAS PERFORMED THAT CONFIRMED LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE IN WHICH THE TWO EXISTING LEADS WERE EXPLANTED AND REPLACED WITH ONE NEW LEAD. DURING THE PROCEDURE IT WAS NOTED THAT ONE OF THE LEADS EXHIBITED POTENTIAL DAMAGE THAT MAY HAVE BEEN ASSOCIATED WITH SCAR TISSUE AND WAS DIFFICULT TO EXPLANT, THEREFORE THE PHYSICIAN ELECTED TO REPLACE THE LEAD. ONLY ONE NEW LEAD WAS IMPLANTED DUE TO DIFFICULTY PLACING THE LEAD INTO THE EPIDURAL SPACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE EXPLANTED LEADS WERE DISPOSED OF AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494363 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70 5061245 08714729797821

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention