BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 10192781 · Received June 24, 2020

    Report

    Report Number
    3006630150-2020-02605
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    June 9, 2020
    Report Date
    June 24, 2020
    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 · 0

    ADDITIONAL SUSPECT DEVICES: ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2317700; MODEL: SC-2317-70; SERIAL: (B)(4); BATCH: 5153702.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STIMULATION NO LONGER COVERED PATIENTS PAIN AREAS DUE TO HIGH IMPEDANCES THAT WERE THE RESULT OF A NON-DEVICE RELATED FALL. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE LEADS, AND IS DOING WELL POST-OPERATIVELY.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND THE COMPLAINT OF HIGH IMPEDANCES AND LOSS OF STIMULATION COULD NOT BE CONFIRMED. RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THE INVESTIGATION IS UNABLE TO DETERMINE A PROBABLE CAUSE FOR THE COMPLAINT; THEREFORE, THE CAUSE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION NO LONGER COVERED PATIENTS PAIN AREAS DUE TO HIGH IMPEDANCES THAT WERE THE RESULT OF A NON-DEVICE RELATED FALL. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE LEADS, AND IS DOING WELL POST-OPERATIVELY. DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655624 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5153698 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention