BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 12930232 · Received December 3, 2021

    Report

    Report Number
    3006630150-2021-06934
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    October 18, 2021
    Report Date
    December 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    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)(4), BATCH: 7090254. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7090705.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WENT DIRECT TO IMPLANT WITHOUT A TRIAL AND EXPERIENCED INADEQUATE STIMULATION. THE PATIENT STATED THAT THEY HAD BOTH PRE-EXISTING AND NEW PAIN INCLUDING DISCOMFORT AROUND THE CLIK ANCHORS. IT WAS NOTED THAT THE PATIENT EXPERIENCED A HIGH LEVEL OF CONSTANT PAIN AND DISCOMFORT AROUND THEIR FEET AND MID-BACK SECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT THE IMPLANTABLE PULSE GENERATOR (IPG) AND TWO LEADS. THE PATIENT IS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823551 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 368885 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention