BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 23126871 · Received September 23, 2025

    Report

    Report Number
    3006630150-2025-07924
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    September 3, 2025
    Report Date
    October 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352700 MODEL: SC-2352-70 SERIAL: (B)(6). BATCH: 3216494 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700 MODEL: SC-2352-70 SERIAL: (B)(6). BATCH: 7070955 UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. ADDITIONAL INFORMATION STATED THAT ALL EXPLANTED ITEMS DISCARDED PER HOSPITAL POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. ADDITIONAL INFORMATION STATED THAT ALL EXPLANTED ITEMS DISCARDED PER HOSPITAL POLICY. ADDITIONAL INFORMATION STATED THAT THE PATIENT DID GREAT POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218128 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 522878 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention