BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 21546972 · Received March 7, 2025

    Report

    Report Number
    3006630150-2025-01311
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    February 14, 2025
    Report Date
    April 25, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729760559
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7086626. PRODUCT FAMILY: SCS-ADAPTERS. UPN: M365SC9208150. MODEL: SC-9208-15. SERIAL: (B)(6). BATCH: 7074145. PRODUCT FAMILY: SCS-ADAPTERS. UPN: M365SC9208150. MODEL: SC-9208-15. SERIAL: (B)(6). BATCH: 7073088.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE <QRB>. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7086626. UDI: (B)(4). PRODUCT FAMILY: SCS-ADAPTERS. UPN: M365SC9208150. MODEL: SC-9208-15. SERIAL: (B)(6). BATCH: 7074145. UDI: (B)(4). PRODUCT FAMILY: SCS-ADAPTERS. UPN: M365SC9208150. MODEL: SC-9208-15. SERIAL: (B)(6). BATCH: 7073088. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS CURRENTLY UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS CURRENTLY UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.ADDITIONAL INFORMATION WAS RECEIVED THAT THE (SCS) SYSTEM UNDERWENT AN EXPLANT PROCEDURE BECAUSE PATIENT HAS LOST WEIGHT. THE PATIENT WAS DOING FINE POST OPERATIVELY. THE CURRENT LOCATION OF THE DEVICE REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592221 NA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-3138-35 7086586 08714729760559

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention