BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME

    MDR report key: 24705055 · Received March 26, 2026

    Report

    Report Number
    3006630150-2026-01824
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    February 10, 2026
    Report Date
    May 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED FEW WEEKS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-8336-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7090992, MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318, BATCH/LOT NUMBER: 37746975, MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POCKET SITE SHORTLY AFTER THE IMPLANT PROCEDURE. SYMPTOMS OF CHILLS AND FEVER WERE NOTED. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS NOT DEVICE RELATED AND WAS DUE TO PATIENTS IMPROPER WOUND CARE FOLLOWING THE SURGERY. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL DEVICE COMPONENTS WERE REMOVED AND KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817 WAVEWRITER ALPHA? PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1432 230713 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention