BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 19876910 · Received July 31, 2024

    Report

    Report Number
    3006630150-2024-04993
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    September 9, 2021
    Report Date
    April 28, 2026
    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
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3- APPROXIMATED BASED ON THE DATE OF EXPLANT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7080289/7080343.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AS THE PATIENT COULD NOT PROGRAMMED THE DEVICE CORRECTLY. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED AS THEY WERE DISCARDED. NO DEVICE MALFUNCTION WAS SUSPECTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SPINAL CORD STIMULATION SYSTEM WAS REMOVED DUE TO PATIENT NOT RECEIVING ADEQUATE PAIN RELIEF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AS THE PATIENT COULD NOT PROGRAMMED THE DEVICE CORRECTLY. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED AS THEY WERE DISCARDED. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297416 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 371906 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1