BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 19218411 · Received April 30, 2024

    Report

    Report Number
    3006630150-2024-02766
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: BRAND NAME: LINEAR 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 2000021000. BRAND NAME: LINEAR 3-6, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 19728572, BRAND NAME: PRECISION MONTAGE MRI, UPN: M365SC12000, MODEL: SC-1200, SERIAL: (B)(6), BATCH: 352939. BRAND NAME: LINEAR 3-6, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 7070225.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION FROM THE SPINAL CORD STIMULATOR (SCS) SYSTEMS AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT IS DOING WELL POST OPERATIVELY. NO DEVICES WILL BE RETURNED AS THEY WERE DISCARDED BY THE FACILITY. NO ADDITIONAL INFORMATION WAS PROVIDED DESPITE GOOD FAITH EFFORTS AS THE PHYSICIAN DOES NOT DISCLOSE PATIENT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131724 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 361968 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention