BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 19697771 · Received July 8, 2024

    Report

    Report Number
    3006630150-2024-04402
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    June 21, 2024
    Report Date
    October 3, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729837145
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: INFINION 16. UPN: M365SC231670E0. MODEL: SC-2316-70E. SERIAL: (B)(6). BATCH: (B)(6). SC-2316-70E 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-2316-70E 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: INFINION 16. UPN: M365SC231670E0. MODEL: SC-2316-70E. SERIAL: (B)(6). BATCH: 7081659.

    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 LEADS WERE REMOVED AND REPLACED WITH A NEW ONE. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY AND THE PATIENT WAS NOTED TO HAVE RECOVERED.

    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 LEADS WERE REMOVED AND REPLACED WITH A NEW ONE. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY AND THE PATIENT WAS NOTED TO HAVE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390616 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70E 7081683 08714729837145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention