BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME 16

    MDR report key: 25023844 · Received April 28, 2026

    Report

    Report Number
    3006630150-2026-02733
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 28, 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
    OK, 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: MODEL NUMBER/CATALOG NUMBER: SC-9218-15 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7082998 MODEL/CATALOG DESCRIPTION: PRECISION M8 ADAPTER 15CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-9218-15 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7080089 MODEL/CATALOG DESCRIPTION: PRECISION M8 ADAPTER 15CM UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE BATTERY SITE. SYMPTOMS OF SORENESS AND TENDERNESS WERE NOTED. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND 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
    552013 WAVEWRITER ALPHA? PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 245997 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1