BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 11613190 · Received April 5, 2021

    Report

    Report Number
    3006630150-2021-01337
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    December 10, 2020
    Report Date
    April 5, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M3652317500, MODEL: 2317-50 , SERIAL: (B)(4), LOT: 5102573.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION COVERAGE ON THE RIGHT SIDE DUE TO HIGH IMPEDANCES DISPLAYED ON THE SPINAL CORD STIMULATOR LEAD. TROUBLESHOOTING CONDUCTED FOUND THE IMPEDANCES CHANGED WHEN THE PATIENT WAS PLACED IN DIFFERENT BODY POSITIONS. THE DEVICE WAS REPROGRAMMED, HOWEVER, THE IMPEDANCES REOCCURRED AND THE PHYSICIAN THEN SUSPECTED THE DEVICE WAS NOT WORKING AS INTENDED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513318 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5068574 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention