BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 16120292 · Received January 9, 2023

    Report

    Report Number
    3006630150-2022-07566
    Event Type
    Injury
    Date Received
    January 9, 2023
    Date of Event
    November 28, 2022
    Report Date
    January 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: EXACT DATE UNKNOWN, EVENT OCCURRED THREE WEEKS AGO FROM THE DATE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218700; MODEL: SC-2218-70; SERIAL: (B)(4); BATCH: 7082043/7082046.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND ALL EXPLANTED DEVICES WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510811 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1416 206481 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention