BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA ?

    MDR report key: 24428729 · Received February 24, 2026

    Report

    Report Number
    3006630150-2026-01068
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    September 16, 2019
    Report Date
    May 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRO CODE (PRODUCT CODE): LGW, QRB INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INVESTIGATION CONCLUSION: THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND THE COMPLAINT AS REPORTED COULD NOT BE CONFIRMED. RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS UNABLE TO DETERMINE A PROBABLE CAUSE FOR THE COMPLAINT AND THE CONCLUSION CODE UNABLE TO EXCLUDE DEVICE PROBLEM WILL BE USED.

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRO CODE (PRODUCT CODE): LGW, QRB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE DUE TO AN UNKNOWN REASON. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED IPG WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE DUE TO AN UNKNOWN REASON. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED IPG WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13280 PRECISION SPECTRA ? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1132 17802243 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention