BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 12425277 · Received September 3, 2021

    Report

    Report Number
    3006630150-2021-04959
    Event Type
    Injury
    Date Received
    September 3, 2021
    Date of Event
    July 6, 2021
    Report Date
    September 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    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: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(4), LOT: 7072668.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION PATIENT EXPERIENCED PAIN AT THE THORACIC INCISION SITE. IN ADDITION, HIGH IMPEDANCES WERE DISPLAYED ON THE LEADS, HOWEVER, DEVICE REPROGRAMMING AROUND THE IMPEDANCES WAS SUCCESSFUL. THE PHYSICIAN SUSPECTED THAT EXCHANGING THE LINEAR LEADS FOR A PADDLE LEAD WOULD RESOLVE THE PAIN. THEREFORE, PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE TWO LEADS WERE REPLACED WITH A PADDLE LEAD TO ALLEVIATE THE PAIN. THE PATIENT IS DOING WELL POST-OPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317186 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7072605 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention