BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 24758863 · Received April 1, 2026

    Report

    Report Number
    3006630150-2026-01995
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    October 9, 2025
    Report Date
    May 4, 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
    MI, 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-2408-74 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7077794 MODEL/CATALOG DESCRIPTION: AVISTA MRI PERC LEAD KIT 74 CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2408-74 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7077078 MODEL/CATALOG DESCRIPTION: AVISTA MRI PERC LEAD KIT 74 CM UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN FEW MONTHS PRIOR THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD NUMBNESS AND TINGLING SENSATION EVEN WHEN THE SPINAL CORD STIMULATOR (SCS) WAS OFF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD NUMBNESS AND TINGLING SENSATION EVEN WHEN THE SPINAL CORD STIMULATOR (SCS) WAS OFF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18162 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 779314 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1