BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 16387672 · Received February 16, 2023

    Report

    Report Number
    3006630150-2023-00637
    Event Type
    Injury
    Date Received
    February 16, 2023
    Date of Event
    January 20, 2023
    Report Date
    February 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7080153. PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12320, MODEL: SC-1232, SERIAL: (B)(4), BATCH: 557560.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION THAT CAUSED THE TISSUE TO BECOME WEAK AND UNABLE TO HOLD THE LEAD SUTURES IN PLACE. AS A RESULT, THE LEAD MIGRATED WHICH WAS CONFIRMED THROUGH X-RAY. THE PATIENT LOST RELIEF AND REPROGRAMMING WAS ATTEMPTED, HOWEVER, IT ONLY CAUSED RIB STIMULATION. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS NOT DEVICE RELATED AND SUSPECTED THAT THE CAUSE WAS PATIENTS POOR HYGIENE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE AND THE EXPLANTED DEVICES WERE DISCARDED. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND WAS RECOVERING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359600 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7078503 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Required Intervention