BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 21381700 · Received February 13, 2025

    Report

    Report Number
    3006630150-2025-00709
    Event Type
    Injury
    Date Received
    February 13, 2025
    Date of Event
    January 23, 2023
    Report Date
    March 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    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

    BLOCK B3: DATE APPROXIMATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: INFINION CX, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6).

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE APPROXIMATE ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: INFINION CX UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 5035187 AND 5030606.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD NOT USED HER SPINAL CORD STIMULATION (SCS) SYSTEM FOR THE PAST TWO YEARS. THE PATIENT HAD PAIN IN HER LEFT LEG THAT HAD WORSENED OVER TIME. PREVIOUSLY THE SCS WAS ABLE TO COVER THE PAIN. THE PHYSICIAN RECOMMENDED THAT THE STIMULATION BE TRIED AGAIN TO COVER THE PAIN. THE PATIENT INSISTED THAT SHE WANTED THE STIMULATOR SYSTEM EXPLANTED, CITING THE POSSIBILITY OF WANTING AN MAGNETIC RESONANCE IMAGING (MRI) IN THE FUTURE. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SYSTEM WAS EXPLANTED. THE PATIENT IS RECOVERING WITHOUT ISSUE. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED AT THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD NOT USED HER SPINAL CORD STIMULATION (SCS) SYSTEM FOR THE PAST TWO YEARS. THE PATIENT HAD PAIN IN HER LEFT LEG THAT HAD WORSENED OVER TIME. PREVIOUSLY THE SCS WAS ABLE TO COVER THE PAIN. THE PHYSICIAN RECOMMENDED THAT THE STIMULATION BE TRIED AGAIN TO COVER THE PAIN. THE PATIENT INSISTED THAT SHE WANTED THE STIMULATOR SYSTEM EXPLANTED, CITING THE POSSIBILITY OF WANTING AN MAGNETIC RESONANCE IMAGING (MRI) IN THE FUTURE. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SYSTEM WAS EXPLANTED. THE PATIENT IS RECOVERING WITHOUT ISSUE. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED AT THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624023 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1132 21509536 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention