BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 18115756 · Received November 10, 2023

    Report

    Report Number
    3006630150-2023-06945
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    October 19, 2023
    Report Date
    November 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN:M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7083229; PRODUCT FAMILY: SCS-IPG-PC, UPN: M365SC14320, MODEL: SC-1432, SERIAL:(B)(6), BATCH: 222161.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE, WHICH WENT WELL, WITH NO VISIBLE OR NOTICEABLE COMPLICATIONS, IT WAS NOTICED IN THE RECOVERY AREA THAT THE PATIENT WAS NOT ABLE TO MOVE HER RIGHT LEG. AN X-RAY WAS TAKEN BUT THE PHYSICIAN DID NOT SEE ANYTHING WRONG WITH THE PLACEMENT OF THE SCS DEVICE. AFTER A SHORT PERIOD OF OBSERVATION, THE PHYSICIAN MADE THE DECISION TO TRANSFER THE PATIENT TO THE HOSPITAL FOR FURTHER TESTING. THE PATIENT HAD MULTIPLE INCONCLUSIVE TESTS, INCLUDING MAGNETIC RESONANCE IMAGING (MRI). AFTER AN OVERNIGHT STAY IN THE HOSPITAL, THE PATIENTS SYMPTOMS HAD NOT IMPROVED BUT THERE WAS NOT A KNOWN CAUSE FOR HER CONDITION. THE PHYSICIAN CHOSE TO EXPLANT THE SCS SYSTEM. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY. POST OPERATIVELY, THE PATIENT WAS IN REHAB AND HER STAPLES WERE REMOVED. THE PATIENT TOLD THE PHYSICIANS OFFICE THAT SHE'S DOING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2198564 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7083130 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention