BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA ?

    MDR report key: 23384170 · Received October 24, 2025

    Report

    Report Number
    3006630150-2025-09562
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    May 22, 2025
    Report Date
    October 24, 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EXPLANT DATE USED AS THE APPROXIMATED DATE OF EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 5160405, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 5173114, UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, BATCH: 24068771, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE POCKET SITE AND THE PLACEMENT OF THE IMPLANTABLE PULSE GENERATOR (IPG) WOULD RUB UP AGAINST THINGS INCLUDING CLOTHES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND HAD FULLY RECOVERED. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550799 PRECISION SPECTRA ? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1132 202955 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention