BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 21496868 · Received February 28, 2025

    Report

    Report Number
    3006630150-2025-01110
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    January 28, 2025
    Report Date
    March 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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-PADDLE LEADS-MRI. UPN: M365SC8416700. MODEL: SC-8416-70. SERIAL: (B)(6). BATCH: 7071629. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138250. MODEL: SC-3138-25. SERIAL: (B)(6). BATCH: 7062170/7062589.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY. NO FURTHER INFORMATION WAS OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS OBTAINED STATING THAT THE PATIENT HAD THE SCS DEVICE EXPLANTED DUE TO THE PATIENT HAVING INADEQUATE STIMULATION. DEVICE MIGRATION WAS ALSO NOTED VIA X-RAY ON THE DAY OF THE EXPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY. NO FURTHER INFORMATION WAS OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557690 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 376894 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention