BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 18844832 · Received March 6, 2024

    Report

    Report Number
    3006630150-2024-01237
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    February 14, 2024
    Report Date
    March 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797821
    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 16, UPN: M365SC2316700, MODEL: SC-2316-70, SERIAL: (B)(6), BATCH: 7083853.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SPINAL CORD STIMULATION (SCS) TRIAL TESTING PERIOD, THE PATIENT EXPERIENCED NUMBNESS AND CHANGE IN STRENGTH IN HER LEFT HAND SINCE THE PROCEDURE. THE PHYSICIAN DECIDED TO EXPLANT THE TRIAL LEADS EARLY TO BE ON THE SAFE SIDE. POSTOPERATIVELY THE NUMBNESS AS MINIMALLY RESOLVED, BUT NOT COMPLETELY. THE PATIENT REPORTED A BRUISE ON THE OUTSIDE OF HER UPPER ARM WHICH SHE BELIEVES TO BE RELATED TO HER SYMPTOMS. THE PATIENT UNDERWENT A MAGNETIC RESONANCE IMAGING (MRI) AND THERE WAS NO EVIDENCE OF CORD CONTUSION OR HEMATOMA. THE PHYSICIAN ASSESSED THAT THERE WAS NO CLEAR CAUSE FOR THE PATIENTS SYMPTOMS. HE FELT THEY WERE LIKELY UNRELATED TO THE PROCEDURE OR STIMULATOR, AND RATHER SYMPTOMS OF MINOR TRAUMA OR FIBROMYALGIA. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111618 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70 7086777 08714729797821

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention