BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA?

    MDR report key: 24715382 · Received March 30, 2026

    Report

    Report Number
    3006630150-2026-01861
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    February 16, 2026
    Report Date
    May 20, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861539
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS AND THE COMPLAINT AS REPORTED WAS NOT ABLE TO BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPPING. NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. THEREFORE, IN THE ABSENCE OF DEVICE RETURN AND ANALYSIS THE LIKELY ROOT CAUSE COULD NOT BE ESTABLISHED. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). AS A RESULT, THE PHYSICIAN RECOMMENDED UPGRADING TO NEWER TECHNOLOGY TO IMPROVE PAIN MANAGEMENT. CONSEQUENTLY, THE IPG WAS REPLACED. POSTOPERATIVELY, THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE EXPLANTED DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). AS A RESULT, THE PHYSICIAN RECOMMENDED UPGRADING TO NEWER TECHNOLOGY TO IMPROVE PAIN MANAGEMENT. CONSEQUENTLY, THE IPG WAS REPLACED. POSTOPERATIVELY, THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE EXPLANTED DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595244 PRECISION SPECTRA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1032B 145158 08714729861539

    Patients

    Seq Age Sex Outcome Treatment
    1