BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 21999839 · Received May 11, 2025

    Report

    Report Number
    3006630150-2025-03256
    Event Type
    Injury
    Date Received
    May 11, 2025
    Date of Event
    March 1, 2025
    Report Date
    May 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL:SC-8216-50, SERIAL: (B)(6), BATCH: 7072067, UDI:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IMPLANT SITE. THE PHYSICIAN PRESCRIBED ANTIBIOTICS. IT WAS ALSO NOTED THAT THE PATIENT WAS DIABETIC. NO FURTHER INFORMATION COULD BE OBTAINED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IMPLANT SITE. THE PHYSICIAN PRESCRIBED ANTIBIOTICS. IT WAS ALSO NOTED THAT THE PATIENT WAS DIABETIC. NO FURTHER INFORMATION COULD BE OBTAINED ADDITIONAL INFORMATION WAS RECEIVED THAT INFECTION WAS NO LONGER PRESENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IMPLANT SITE. THE PHYSICIAN PRESCRIBED ANTIBIOTICS. IT WAS ALSO NOTED THAT THE PATIENT WAS DIABETIC. NO FURTHER INFORMATION COULD BE OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT INFECTION WAS NO LONGER PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466968 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 761632 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1