BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 21931596 · Received April 29, 2025

    Report

    Report Number
    3006630150-2025-02911
    Event Type
    Injury
    Date Received
    April 29, 2025
    Date of Event
    May 28, 2024
    Report Date
    April 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    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

    B3: ESTIMATED BASED ON THE GFE RESPONSE FROM THE SALES REPRESENTATIVE, AS THE PATIENT WAS AWARE OF THE ISSUE IMMEDIATELY AFTER THE INITIAL IMPLANT AND REVISION. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7131139, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7133342. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS WERE REPLACED DUE TO INADEQUATE STIMULATION, AS THE TARGETED PAIN AREAS WERE NOT COVERED SATISFACTORILY. ALTHOUGH THE EXACT CAUSE REMAINS UNKNOWN, IT IS SUSPECTED THAT THE INITIAL PLACEMENT OF THE LEADS MAY HAVE ALSO CONTRIBUTED TO THE PROBLEM. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THEIR IPG AND LEADS WERE EXPLANTED AND REPLACED. THE IPG AND LEADS WERE DISPOSED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238223 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 591101 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention