BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 20701040 · Received November 15, 2024

    Report

    Report Number
    3006630150-2024-07900
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    October 22, 2024
    Report Date
    November 15, 2024
    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

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN:M365SC8336500 MODEL:SC-8336-50 SERIAL: (B)(6) BATCH:7072006. PRODUCT FAMILY: SCS-PADDLE LEADS UPN:M365SC8216500 MODEL:SC-8216-50 SERIAL: (B)(6) BATCH: 7070801. PRODUCT FAMILY: SCS-LEAD FIXATION UPN:M365SC43180 MODEL:SC-4318 BATCH:25386335/26475588.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308080 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 370092 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention