BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 13106139 · Received December 29, 2021

    Report

    Report Number
    3006630150-2021-07327
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    April 8, 2021
    Report Date
    December 29, 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
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: 7071819.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS AND INADEQUATE STIMULATION DUE TO LEAD FRACTURE AND HIGH IMPEDANCES SECONDARY TO LEAD MIGRATION. IT WAS ALSO STATED THAT THE PATIENT WAS EXPERIENCING WORSENING BACK PAIN. REPROGRAMMING ATTEMPTED BUT STILL STIMULATION ISSUES PERSIST. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006186 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7071751 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention