BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 22178531 · Received June 10, 2025

    Report

    Report Number
    3006630150-2025-04272
    Event Type
    Injury
    Date Received
    June 10, 2025
    Date of Event
    March 31, 2025
    Report Date
    June 25, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729121336
    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

    THE REPORTED IPG AND LEAD HAD NO UDI INFORMATION SINCE THESE PRODUCTS WERE MANUFACTURED PRIOR TO IMPLEMENTATION OF THE UDI REGULATION AND AS A RESULT, THE COMPLETE UDI IS NOT AVAILABLE. APPLICABLE US PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2138700, MODEL: SC-2138-70, SERIAL: (B)(6), BATCH: 165064, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2138700, MODEL: SC-2138-70, SERIAL: (B)(6), BATCH: A22511, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2138700, MODEL: SC-2138-70, SERIAL: (B)(6), BATCH: 164911, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2138700, MODEL: SC-2138-70, SERIAL: (B)(6), BATCH: 161397, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. ADDITIONAL INFORMATION RECEIVED THAT PATIENT WANTED A MAGNETIC RESONANCE IMAGING (MRI) THAT WAS WHY THE IPG WAS EXPLANTED. THE EXPLANTED DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718150 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110 168157 08714729121336

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention