BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 21698383 · Received March 26, 2025

    Report

    Report Number
    3006630150-2025-01864
    Event Type
    Injury
    Date Received
    March 26, 2025
    Date of Event
    March 6, 2025
    Report Date
    March 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500 MODEL: SC-2317-50 SERIAL: (B)(6). BATCH: 5181097/7070429. PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8336500 MODEL: SC-8336-50 SERIAL: (B)(6). BATCH: 7043106.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131539 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 346076 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention