BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 18983463 · Received March 26, 2024

    Report

    Report Number
    3006630150-2024-01803
    Event Type
    Injury
    Date Received
    March 26, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: SPECTRA WAVE WRITER UPN: M365SC11600 MODEL: SC-1160 SERIAL: (B)(6). BATCH: 361433. BRAND NAME: LINEAR 3-6 UPN: M365SC2366700 MODEL: SC-2366-70 SERIAL: (B)(6) BATCH: 7073184. BRAND NAME: LINEAR 3-6 UPN: M365SC2366700 MODEL: SC-2366-70 SERIAL: (B)(6). BATCH: 7073206.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM HOWEVER THE CAUSE OF THE PAIN IS UNKNOWN. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE IPG POCKET WAS REVISED. THE PATIENTS' SECOND IPG WAS EXPLANTED AND UPGRADED WITH A NEW DEVICE PER THE PATIENTS' REQUEST AS THEY STATED THAT THE IPG WAS NOT WORKING PROPERLY, HOWEVER NO OTHER INFORMATION WAS PROVIDED. THE PATIENTS' TWO LEADS WERE REPOSITIONED DUE TO MIGRATION WHICH WAS CONFIRMED WITH FLUOROSCOPY, CAUSING THE PATIENT TO EXPERIENCE INADEQUATE STIMULATION. THE PATIENT IS DOING WELL POST-OPERATIVELY. THE EXPLANTED IPG WILL NOT BE RETURNED AS IT WAS DISPOSED OF BY THE FACILITY, AND THE REMAINING DEVICES REMAIN IMPLANTED, THEREFORE NO DEVICES WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985997 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 551614 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention