BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 22491125 · Received July 13, 2025

    Report

    Report Number
    3006630150-2025-05445
    Event Type
    Injury
    Date Received
    July 13, 2025
    Date of Event
    June 18, 2025
    Report Date
    August 8, 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
    MO, 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 SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 7082496/7082497, UDI: (B)(4). PRODUCT FAMILY: CLIK X MRI ANCHOR, UPN: M365SC43190, MODEL: SC-4319, SERIAL:, BATCH: 32546214, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION DUE TO SURGICAL INCISION WAS NOT HEALING ALL THE WAY. THE PATIENT WAS SEEING A WOUND SPECIALIST WHO SAID IT COULD HAVE BEEN BECAUSE OF BACTERIA IN THE WOUND. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. NO FURTHER INFORMATION WAS OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION DUE TO SURGICAL INCISION WAS NOT HEALING ALL THE WAY. THE PATIENT WAS SEEING A WOUND SPECIALIST WHO SAID IT COULD HAVE BEEN BECAUSE OF BACTERIA IN THE WOUND. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. NO FURTHER INFORMATION WAS OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729456 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 765717 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| O