BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 15451891 · Received September 19, 2022

    Report

    Report Number
    3006630150-2022-04871
    Event Type
    Injury
    Date Received
    September 19, 2022
    Date of Event
    August 26, 2022
    Report Date
    September 19, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC231650E0; MODEL: SC-2316-50E; SERIAL: (B)(4); BATCH: 7172468.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A TRIAL PROCEDURE THE PATIENT NOTICE SOME BLOOD ON THE BANDAGES. THE PATIENT REMOVE THE BANDAGE AND PULL THE LEADS. IT WAS MENTIONED THAT FOLLOWING THE LEAD PULL THE PATIENT WAS EXPERIENCING PAIN AT THE INCISION SITE AND DIFFICULTY WALKING. THE LEADS WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2792624 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7172442

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention