BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 12841019 · Received November 18, 2021

    Report

    Report Number
    3006630150-2021-06558
    Event Type
    Injury
    Date Received
    November 18, 2021
    Date of Event
    June 2, 2021
    Report Date
    November 18, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED (B)(6) 2021 FROM THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 5160519. PRODUCT FAMILY: SCS-IPG-R, UPN: M365SC11600, MODEL: SC-1160, SERIAL: (B)(4), BATCH: 361196.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737419 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5161276 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention