BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 20701286 · Received November 16, 2024

    Report

    Report Number
    3006630150-2024-07905
    Event Type
    Injury
    Date Received
    November 16, 2024
    Date of Event
    April 24, 2024
    Report Date
    November 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED SIX MONTHS AGO FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7102207/7101947.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANTABLE PULSE GENERATOR (IPG) AND SPINAL CORD STIMULATION (SCS) LEAD REPLACEMENT PROCEDURE DUE TO AN UNKNOWN REASON. IT WAS NOTED THAT DURING THE PROCEDURE, THE LEADS WERE ATTEMPTED TO BE ADJUSTED BUT THE SCAR TISSUE PREVENTED IN ADVANCING THE LEAD. A NEW LEAD WAS ATTEMPTED BUT SCAR TISSUE CONTINUED TO PREVENT PLACEMENT. ONLY ONE LEAD WAS EXPLANTED, AND THE OTHER LEAD REMAINS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308091 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 529545 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention