BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 21754706 · Received April 2, 2025

    Report

    Report Number
    3006630150-2025-02078
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    December 25, 2024
    Report Date
    May 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7100312/7100263. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK (D4): UNIQUE IDENTIFIER (UDI).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE SHOOTING PAIN RANDOMLY AND BELIEVED TO BE STIMULATOR RELATED. X-RAYS TAKEN REVEALED THAT THE DEVICE WAS WORKING PROPERLY. THE PATIENT UNDERWENT EXPLANT PROCEDURE. NO MALFUNCTION SUSPECTED. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL THE DEVICE COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE SHOOTING PAIN RANDOMLY AND BELIEVED TO BE STIMULATOR RELATED. X-RAYS TAKEN REVEALED THAT THE DEVICE WAS WORKING PROPERLY. THE PATIENT UNDERWENT EXPLANT PROCEDURE. NO MALFUNCTION SUSPECTED. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE SHOOTING PAIN RANDOMLY AND BELIEVED TO BE STIMULATOR RELATED. X-RAYS TAKEN REVEALED THAT THE DEVICE WAS WORKING PROPERLY. THE PATIENT UNDERWENT EXPLANT PROCEDURE. NO MALFUNCTION SUSPECTED. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL THE DEVICE COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2301897 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 770536 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention