BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24845600 · Received April 10, 2026

    Report

    Report Number
    3006630150-2026-02220
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 10, 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
    JA
    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: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7081829, UDI#: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7082532, UDI#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION LOCATED AT THE BUTTOCKS, IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTATION SITE, AND IN THE BACK AT THE LEAD FIXATION SITE. THE CAUSE OF THE INFECTION IS UNKNOWN. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT TO EXPLANT ALL DEVICES. A CULTURE WAS TAKEN AND METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) WAS CONFIRMED. THE PATIENT HAS BEEN ADMITTED TO THE HOSPITAL AND UNDERWENT ANTIBIOTIC TREATMENT. THE PATIENT IS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373829 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 788996 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization| R