BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10924226 · Received November 30, 2020

    Report

    Report Number
    3006630150-2020-05929
    Event Type
    Injury
    Date Received
    November 30, 2020
    Date of Event
    December 14, 2019
    Report Date
    November 30, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7071007/7071007.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD PERSISTENT AND WORSENING PAIN AT IPG SITE AND MIDLINE INCISION. THE PATIENT HAD TRIGGER POINT INJECTIONS WITH NO RELIEF. THE PATIENT UNDERWENT A REVISION PROCEDURE TO HAVE THE IPG ADJUSTED. THE PROCEDURE WENT ACCORDING TO PLAN WITH NO COMPLICATIONS AND THE PATIENT IS DOING GREAT. THE BATTERY ADJUSTMENT WAS DEEMED MEDICALLY NECESSARY DUE TO PATIENT'S DISCOMFORT OF CURRENT BATTERY POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389026 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 361379 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention