BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 19943549 · Received August 8, 2024

    Report

    Report Number
    3006630150-2024-05196
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    December 18, 2023
    Report Date
    October 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: INFINION CX, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7072268.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: INFINION CX UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6) BATCH: 7072268 SC-2317-70 SN (B)(6) VISUAL AND X-RAY INSPECTION OF THE RETURNED LEAD REVEALED THAT THIS LEAD WAS BENT/KINKED NEAR THE SET SCREW MARK OF THE CLIK ANCHOR AND MULTIPLE CABLES WERE COMPLETELY BROKEN AT THIS LOCATION. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. LABORATORY ANALYSIS DETERMINED THAT THE CAUSE OF THE BROKEN CABLES IS DUE TO MECHANICAL STRESS FROM POSSIBLE FLEXING OF THE LEAD AT THE EXIT POINT OF THE CLIK ANCHOR. SC-2317-70 SN (B)(6) VISUAL AND X-RAY INSPECTION OF THE RETURNED LEAD REVEALED THAT THIS LEAD WAS BENT/KINKED NEAR THE SET SCREW MARK OF THE CLIK ANCHOR AND MULTIPLE CABLES WERE COMPLETELY BROKEN AT THIS LOCATION. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. LABORATORY ANALYSIS DETERMINED THAT THE CAUSE OF THE BROKEN CABLES IS DUE TO MECHANICAL STRESS FROM POSSIBLE FLEXING OF THE LEAD AT THE EXIT POINT OF THE CLIK ANCHOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO THE SPINAL CORD STIMULATION (SCS) LEADS DISPLAYING HIGH IMPEDANCES. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCS LEADS WERE REMOVED AND REPLACED. POST OPERATIVELY, THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO THE SPINAL CORD STIMULATION (SCS) LEADS DISPLAYING HIGH IMPEDANCES. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCS LEADS WERE REMOVED AND REPLACED. POST OPERATIVELY, THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2395488 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7072694 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention