BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 17288073 · Received July 10, 2023

    Report

    Report Number
    3006630150-2023-03995
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    March 12, 2021
    Report Date
    July 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 5160500. PRODUCT FAMILY: SCS-IPG-R, UPN: M365SC11600, MODEL: SC-1160, SERIAL: (B)(6), BATCH: 357888.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PHYSICIAN ASSESSED THE PRESENCE OF HIGH IMPEDANCES MEASUREMENTS ON THE LEAD AND ATTEMPTS TO REPROGRAM THE DEVICE WERE SUCCESSFUL. HOWEVER, THE PATIENT BEGAN EXPERIENCING RAPID IMPLANTABLE PULSE GENERATOR (IPG) BATTERY DEPLETION AND UNDERWENT A REVISION PROCEDURE WHERE THE LEADS AND IPG WERE REPLACED. THE PATIENT DID WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY, AS SUCH, PHYSICAL ANALYSIS COULD NOT BE CONDUCTED IN OUR LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185774 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5159943 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention