BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 23057712 · Received September 15, 2025

    Report

    Report Number
    3006630150-2025-07624
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    August 18, 2025
    Report Date
    September 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE OF THE EXPLANT PROCEDURE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216500 MODEL: SC-8216-50 SERIAL: (B)(6) BATCH: 7071221 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE IMPLANTABLE PULSE GENERATOR (IPG) HAS CRACKED RESULTING IN SPASMS IN THE RIGHT FOOT AND PAIN DURING WALKING, STANDING, OR LYING DOWN. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED DESPITE MULTIPLE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697197 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 373436 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention