BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 21227547 · Received January 24, 2025

    Report

    Report Number
    3006630150-2025-00185
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    August 8, 2024
    Report Date
    May 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8216700. MODEL: SC-8216-70. SERIAL: (B)(6). BATCH: 7071846.

    Additional Manufacturer Narrative · 0

    THE RETURNED IMPLANTABLE PULSE GENERATOR WITH MODEL NUMBER SC-1232 AND A SERIAL NUMBER (B)(6) WAS ANALYZED AND THE ALLEGATION THAT THE PATIENT WAS NO LONGER GETTING ADEQUATE PAIN RELIEF AND WAS HAVING DIFFICULTY KEEPING THE IPG CHARGED HAS BEEN CONFIRMED. UPON REVIEWING THE DATA LOGS, A HIGH DEPLETION RATE WAS IDENTIFIED. THE INVESTIGATION REVEALED THAT THE ASIC CHIP WAS DAMAGED, WHICH LED TO THE REPORTED ALLEGATION. SUCH DAMAGE IS TYPICALLY CAUSED BY THE IPGS EXPOSURE TO EXTERNAL HIGH-VOLTAGE OR HIGH-CURRENT TRANSIENT SOURCES. THE RETURNED SPINAL CORD STIMULATOR LEAD WITH A MODEL NUMBER SC-8216-70 AND A SERIAL NUMBER (B)(6) WAS ANALYZED AND UNABLE TO CONFIRM THE AS REPORTED OBSERVATIONS WITH TESTING OF THE PRODUCT RETURN. HOWEVER VISUAL INSPECTION REVEALED THAT THE PADDLE LEAD WAS CLEANLY CUT INTO TWO PIECES APPROXIMATELY 56 CM FROM THE PADDLE END OF THE LEAD AND ONE THE PROXIMAL PORTION OF THE LEAD WAS NOT RETURNED. ELECTRICAL TEST COULD NOT BE PERFORMED DUE TO THE CUT LEAD BODY. NO OTHER ANOMALIES WERE IDENTIFIED ON THE RETURNED PORTION OF THE LEAD ASIDE FROM THE CLEAN-CUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NO LONGER GETTING ADEQUATE PAIN RELIEF AND WAS HAVING DIFFICULTY KEEPING THE IMPLANTABLE PULSE GENERATOR (IPG) CHARGED. IT WAS ALSO NOTED THAT DURING THE PREVIOUS REVISION PROCEDURE (MFR. REPORT NO. 3006630150-2024-05648), THE PADDLE LEAD WAS CUT. DATABASE ANALYSIS CONFIRMED THE REPORT OF FREQUENT CHARGING. THE IPG WAS DEPLETING AT A FASTER RATE THAN EXPECTED HOWEVER THE CAUSE WAS UNKNOWN. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NO LONGER GETTING ADEQUATE PAIN RELIEF AND WAS HAVING DIFFICULTY KEEPING THE IMPLANTABLE PULSE GENERATOR (IPG) CHARGED. IT WAS ALSO NOTED THAT DURING THE PREVIOUS REVISION PROCEDURE (MFR. REPORT NO. 3006630150-2024-05648), THE PADDLE LEAD WAS CUT. DATABASE ANALYSIS CONFIRMED THE REPORT OF FREQUENT CHARGING. THE IPG WAS DEPLETING AT A FASTER RATE THAN EXPECTED HOWEVER THE CAUSE WAS UNKNOWN. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612079 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 578796 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1