BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 21554211 · Received March 7, 2025

    Report

    Report Number
    3006630150-2025-01368
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    February 12, 2025
    Report Date
    March 7, 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
    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: INFINION CX, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 5178946. BRAND NAME: INFINION CX, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7071353.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION FROM THE SPINAL CORD STIMULATOR (SCS) SYSTEM, REPROGRAMMING WAS PERFORMED HOWEVER IT DID NOT RESOLVE THE LACK OF PAIN RELIEF. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS WERE EXPLANTED AND REPLACED WITH NEW DEVICES. THE PATIENT IS DOING WELL POST OPERATIVELY. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140060 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 361444 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention