BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 20932254 · Received December 13, 2024

    Report

    Report Number
    3006630150-2024-08754
    Event Type
    Injury
    Date Received
    December 13, 2024
    Date of Event
    September 18, 2024
    Report Date
    January 27, 2025
    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
    AZ, 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 Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6). BATCH: 7072125/7072358.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING AS INTENDED. THE PATIENT UNDERWENT AN IPG EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING AS INTENDED. THE PATIENT UNDERWENT AN IPG EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS ALSO NOTED THAT THE LEADS WERE FRAYED RESULTING TO IMPEDANCES, HOWEVER, IT COULD NOT BE DETERMINED IF THE DAMAGE OCCURRED BEFORE OR DURING THE PROCEDURE. THE EXPLANTED IPG WAS NOT RETURNED AND THE LEADS REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922992 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 368559 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention