BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 21694239 · Received March 25, 2025

    Report

    Report Number
    3006630150-2025-01856
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    February 2, 2025
    Report Date
    March 25, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: COVEREDGE X MRI, UPN: M365SC8452700, MODEL: SC-8452-70, SERIAL: (B)(6), BATCH: 7071269.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND DISCOMFORT AT THE SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE ENTIRE SCS SYSTEM WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY. THE PATIENT HAS RECOVERED AND THERE WERE NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694968 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 752090 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention