BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME 16

    MDR report key: 25342917 · Received May 31, 2026

    Report

    Report Number
    3006630150-2026-03656
    Event Type
    Injury
    Date Received
    May 31, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 29, 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
    CA, 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 COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2352-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7081854, MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 50 CM, UNIQUE IDENTIFIER (UDI)#: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2352-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7081848, MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 50 CM, UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A FALL AND WAS NOT GETTING RELIEF DUE TO THE SPINAL CORD STIMULATOR (SCS) LEAD HAD MOVED DOWN. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REVISION PROCEDURE AND THE PHYSICIAN ADDED A NEW LEAD AT A HIGHER POSITION, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED IMPLANTABLE PULSE GENERATOR (IPG) WAS DISPOSED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392219 WAVEWRITER ALPHA? PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 228946 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1