BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 23816197 · Received December 16, 2025

    Report

    Report Number
    3006630150-2025-11460
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    November 17, 2025
    Report Date
    January 26, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 M365SC2318700; MODEL SC-2318-70; SERIAL-LOT (B)(6); BATCH 5006482; UDI (B)(4). PRODUCT FAMILY SCS-LINEAR LEADS; UPN M365SC2318700; MODEL SC-2318-70; SERIAL-LOT (B)(6); BATCH 5003583; UDI (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY SCS-LINEAR LEADS: UPN M365SC2318700, MODEL SC-2318-70, SERIAL-LOT (B)(6), BATCH 5006482, UDI (B)(4). PRODUCT FAMILY SCS-LINEAR LEADS: UPN M365SC2318700, MODEL SC-2318-70, SERIAL-LOT (B)(6), BATCH 5003583, UDI (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MACULOPAPULAR, PRURITIC RASH OVER THE SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) SITE AND SCS LEAD SITES. THE RASH WAS ALSO PRESENT ON THE PATIENTS ENTIRE RIGHT LOW BACK THAT EXTENDED INTO HIS RIGHT ABDOMEN. NOTHING HAPPENED DURING THE IMPLANT PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SCS SYSTEM WAS EXPLANTED, CULTURES WERE TAKEN WHICH CONFIRMED STAPHYLOCOCCUS AUREUS INFECTION. THE INFECTION WAS ASSESSED AS POSSIBLY RELATED TO THE DEVICE AND-OR STIMULATION. THE PATIENT WAS IN STABLE CONDITION POSTOPERATIVELY AND THE EVENT IS RESOLVING. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT HAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MACULOPAPULAR, PRURITIC RASH OVER THE SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) SITE AND SCS LEAD SITES. THE RASH WAS ALSO PRESENT ON THE PATIENTS ENTIRE RIGHT LOW BACK THAT EXTENDED INTO HIS RIGHT ABDOMEN. NOTHING HAPPENED DURING THE IMPLANT PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SCS SYSTEM WAS EXPLANTED, THE INFECTION WAS ASSESSED AS POSSIBLY RELATED TO THE DEVICE AND-OR STIMULATION. THE PATIENT WAS IN STABLE CONDITION POSTOPERATIVELY AND THE EVENT IS RESOLVING. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662072 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 802736 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention