BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 20518195 · Received October 23, 2024

    Report

    Report Number
    3006630150-2024-07264
    Event Type
    Injury
    Date Received
    October 23, 2024
    Date of Event
    May 23, 2023
    Report Date
    October 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(6); BATCH: 7122032 / 7122268.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED CONSTANT PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. IT WAS ALSO NOTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF DESPITE MULTIPLE REPROGRAMMING ATTEMPTS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2557443 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 560772 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention