BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 19904604 · Received August 5, 2024

    Report

    Report Number
    3006630150-2024-05105
    Event Type
    Injury
    Date Received
    August 5, 2024
    Date of Event
    December 1, 2023
    Report Date
    August 5, 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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: LINEAR ST, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7073082. BRAND NAME: LINEAR ST, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7073197. BRAND NAME: LINEAR ST, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7071142. BRAND NAME: LINEAR ST, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7071100.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DID NOT RECEIVE ADEQUATE PAIN RELIEF FROM THE SPINAL CORD STIMULATION (SCS) SYSTEM, AS HE FOUND NO MEANINGFUL DIFFERENCE ON HIS PAIN LEVELS WITH THE SCS SWITCHED ON OR OFF. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SCS SYSTEM WAS EXPLANTED. THE PATIENT HAS FULLY RECOVERED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935622 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 362504 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention