BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 21336782 · Received February 7, 2025

    Report

    Report Number
    3006630150-2025-00537
    Event Type
    Injury
    Date Received
    February 7, 2025
    Date of Event
    November 23, 2024
    Report Date
    March 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(6); BATCH: 7112975. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218700; MODEL: SC-2218-70; SERIAL: (B)(6); BATCH: 7089259.

    Additional Manufacturer Narrative · 0

    SC-2218-50 (SN (B)(6)) THE RETURNED LEAD WAS ANALYZED AND VISUAL INSPECTION REVEALED THAT IT WAS CLEANLY CUT INTO TWO PIECES APPROXIMATELY 21 CM FROM THE DISTAL END. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT WAS NOT CONFIRMED. THE CLEAN-CUT DAMAGE WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NO LONGER FUNCTIONING AS INTENDED AFTER RECEIVING THE END OF SERVICE MESSAGE. IT WAS ALSO NOTED THAT THE LEADS MIGRATED AND HAD HIGH IMPEDANCES, AND THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF. DURING THE REVISION PROCEDURE, THE PHYSICIAN DISCOVERED THAT A LEAD WAS BROKEN AND SEPARATED JUST AFTER THE ANCHOR. THE IPG AND LEADS WERE REPLACED AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE IPG AND ONE LEAD WAS KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NO LONGER FUNCTIONING AS INTENDED AFTER RECEIVING THE END OF SERVICE MESSAGE. IT WAS ALSO NOTED THAT THE LEADS MIGRATED AND HAD HIGH IMPEDANCES, AND THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF. DURING THE REVISION PROCEDURE, THE PHYSICIAN DISCOVERED THAT A LEAD WAS BROKEN AND SEPARATED JUST AFTER THE ANCHOR. THE IPG AND LEADS WERE REPLACED AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE IPG AND ONE LEAD WAS KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125112 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 207682 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention