BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 12405729 · Received September 1, 2021

    Report

    Report Number
    3006630150-2021-04902
    Event Type
    Injury
    Date Received
    September 1, 2021
    Date of Event
    July 27, 2021
    Report Date
    September 1, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2021. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7072296.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS RIGHT LEAD MIGRATED DOWN A FULL LEAD LENGTH AND PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF. LEAD MIGRATION WAS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN THE PHYSICIAN HAD TO OPEN THE MIDLINE AND POCKET TO REMOVE THE MIGRATED LEAD AND START OVER WITH ENTRADA NEEDLE. SUTURE SLEEVE WAS ADDED TO THE RIGHT LEAD. NO DEVICE WAS EXPLANTED. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307452 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5098744 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention