BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 25084714 · Received May 5, 2026

    Report

    Report Number
    3006630150-2026-02901
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 5, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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-2408-56. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7082964. MODEL/CATALOG DESCRIPTION: AVISTA MRI PERC LEAD KIT 56 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2408-56. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7080996. MODEL/CATALOG DESCRIPTION: AVISTA MRI PERC LEAD KIT 56 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4319. SERIAL NUMBER: NA. BATCH/LOT NUMBER: 32358286. MODEL/CATALOG DESCRIPTION: CLIK X MRI ANCHOR. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WORSENING PAIN, NUMBNESS, BURNING SENSATIONS, INCONTINENCE, SEPSIS, AND A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION WHILE IMPLANTED WITH A SPINAL CORD STIMULATOR (SCS) DEVICE. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION THERAPY, INADEQUATE PAIN RELIEF, PAINFUL ELECTRICAL SENSATIONS, AND DEVICE COMMUNICATION FAILURE. THE PATIENT SUBSEQUENTLY UNDERWENT AN SCS SYSTEM EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206541 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 595613 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention