BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME 16

    MDR report key: 23092335 · Received September 18, 2025

    Report

    Report Number
    3006630150-2025-07761
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    October 15, 2024
    Report Date
    December 4, 2025
    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
    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-2352-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7081003. MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 50 CM. THE IPG WAS RECEIVED FOR ANALYSIS AND EXHIBITED NORMAL CHARACTERISTICS AND PASSED ALL TESTS PERFORMED. VISUAL INSPECTION REVEALED THAT THE LEAD BODY WAS CLEANLY CUT INTO TWO PIECES. THE CLEAN CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE. AN ELECTRICAL TEST COULD NOT BE PERFORMED DUE TO THE CUT LEAD BODY. NO OTHER ANOMALIES WERE IDENTIFIED ON THE RETURNED PORTION OF THE LEAD. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) PRODUCT LABEL. ADDITIONALLY, SYSTEM FAILURE, CAN OCCUR AT ANY TIME DUE TO RANDOM FAILURE(S) OF THE COMPONENTS. THESE EVENTS, WHICH MAY INCLUDE DEVICE FAILURE, LEAD BREAKAGE, HARDWARE MALFUNCTIONS, LOOSE CONNECTIONS, ELECTRICAL SHORTS OR OPEN CIRCUITS AND LEAD INSULATION BREACHES, CAN RESULT IN INEFFECTIVE PAIN CONTROL. UNDESIRABLE STIMULATION MAY OCCUR OVER TIME DUE TO CELLULAR CHANGES IN TISSUE AROUND THE ELECTRODES, CHANGES IN ELECTRODE POSITION, LOOSE ELECTRICAL CONNECTIONS AND/OR LEAD FAILURE, ALL OF WHICH ARE KNOWN RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2352-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7081003. MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 50 CM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) WAS NOT ABLE TO PROVIDE PAIN RELIEF SINCE IMPLANTATION. THE PATIENT HAD MULTIPLE RE-PROGRAMMING SESSIONS AND SEEMED TO REPORT GOOD PARESTHESIA COVERAGE BUT HAD NO PAIN RELIEF AND EVEN HAD NEW PAIN AND DISCOMFORT SINCE THE IMPLANT. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCS SYSTEM WAS REMOVED. POST OPERATIVELY, THE PATIENT HAD FULLY RECOVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) WAS NOT ABLE TO PROVIDE PAIN RELIEF SINCE IMPLANTATION. THE PATIENT HAD MULTIPLE RE-PROGRAMMING SESSIONS AND SEEMED TO REPORT GOOD PARESTHESIA COVERAGE BUT HAD NO PAIN RELIEF AND EVEN HAD NEW PAIN AND DISCOMFORT SINCE THE IMPLANT. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCS SYSTEM WAS REMOVED. POST OPERATIVELY, THE PATIENT HAD FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269285 WAVEWRITER ALPHA? PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 228470 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention