BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 20935474 · Received December 15, 2024

    Report

    Report Number
    3006630150-2024-08774
    Event Type
    Injury
    Date Received
    December 15, 2024
    Date of Event
    November 21, 2024
    Report Date
    December 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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: 7153736/7153031.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO NUMBNESS, LEG WEAKNESS, AND URINARY RETENTION FOLLOWING THE IMPLANT OF THE SPINAL CORD STIMULATOR (SCS). IT WAS NOTED THAT THE PATIENT HAD AN INTRADURAL HEMATOMA AS CONFIRMED THROUGH MAGNETIC RESONANCE IMAGING (MRI). THE PHYSICIAN BELIEVED THAT THE SYMPTOMS WERE RELATED TO THE SURGERY AND PLACEMENT OF THE SCS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED AND KEPT BY THE MEDICAL FACILITY. THE PATIENT WAS DISCHARGED TO THE INPATIENT REHABILITATION FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513698 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 765390

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention