BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME 16

    MDR report key: 24696117 · Received March 26, 2026

    Report

    Report Number
    3006630150-2026-01798
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    March 2, 2026
    Report Date
    May 15, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7111590 / 7111561, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318, BATCH/LOT NUMBER: 37686572, 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 IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD SITE. SYMPTOMS OF REDNESS AND DISCHARGE WERE NOTED ON BOTH THE MIDLINE AND POCKET INCISION. IT WAS UNKNOWN IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427204 WAVEWRITER ALPHA? PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 242831 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention