BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 17265579 · Received July 6, 2023

    Report

    Report Number
    3006630150-2023-03926
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    January 1, 2020
    Report Date
    December 12, 2023
    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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED THREE YEARS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 3173272.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT LEADS HAD BEEN FRACTURED FROM THE IPG. ADDITIONAL INFORMATION WAS RECEIVED THAT X-RAY WAS TAKEN WHICH CONFIRMED THAT THE LEADS WERE FRACTURED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND HIGH IMPEDANCES WERE ALSO NOTED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT LEADS HAD BEEN FRACTURED FROM THE IPG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT LEADS HAD BEEN FRACTURED FROM THE IPG. ADDITIONAL INFORMATION WAS RECEIVED THAT X-RAY WAS TAKEN WHICH CONFIRMED THAT THE LEADS WERE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931059 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 20818256 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other| R