BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 20454441 · Received October 15, 2024

    Report

    Report Number
    3006630150-2024-06971
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    August 28, 2024
    Report Date
    October 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 5034068. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 5065258.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED AN INCREASE IN PAIN IN THEIR LOW BACK AND LEGS RESULTING IN INADEQUATE PAIN RELIEF. ADDITIONALLY, THE PATIENT WANTED TO HAVE MAGNETIC RESONANCE IMAGING (MRI) IN THE FUTURE AND THEREFORE UNDERWENT AN EXPLANT PROCEDURE OF THE SCS SYSTEM. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY; THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND SUTURES WERE REMOVED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY PER THEIR PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32928 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 20213408 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Unknown Hospitalization| R