BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 25055828 · Received May 1, 2026

    Report

    Report Number
    3006630150-2026-02804
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    July 21, 2024
    Report Date
    May 1, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE APPROXIMATED, EVENT OCCURRED FIVE MONTHS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-4318 BATCH/LOT NUMBER: 27206490 MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT UNIQUE IDENTIFIER (UDI)#: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2317-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5133826 MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM UNIQUE IDENTIFIER (UDI)#: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2317-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5123961 MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS FREQUENTLY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS ALSO STATED THAT THE PATIENT'S SPINAL CORD STIMULATOR (SCS) LEADS HAD HIGH IMPEDANCE CAUSING ELECTRICAL SHOCKS. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE SPINAL CORD STIMULATOR (SCS) SYSTEM WAS REPLACED WITH AN MRI COMPATIBLE DEVICES AND THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263740 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 510768 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1