BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 21610616 · Received March 14, 2025

    Report

    Report Number
    3006630150-2025-01533
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    January 28, 2025
    Report Date
    April 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7082270/7081751.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE POCKET SITE AND IMPEDANCE ISSUES ON SPINAL CORD STIMULATION (SCS) LEADS. THE PATIENT UNDERWENT SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED PER HOSPITAL POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE POCKET SITE AND IMPEDANCE ISSUES ON SPINAL CORD STIMULATION (SCS) LEADS. THE PATIENT UNDERWENT SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640958 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 574608

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention