BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 24793342 · Received April 6, 2026

    Report

    Report Number
    3006630150-2026-02094
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2408-56, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 20873237, 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: 20873237, MODEL/CATALOG DESCRIPTION: AVISTA MRI PERC LEAD KIT 56 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857149 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 536653 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention