BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 15844043 · Received November 22, 2022

    Report

    Report Number
    3006630150-2022-06455
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    August 12, 2022
    Report Date
    November 22, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS, UPN: (B)(4), MODEL: SC-9218-15, SERIAL: (B)(4), BATCH: 7022654 / 7055919.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING OVERSTIMULATION AND PAIN AROUND THE IPG SITE WHEN STIMULATION WAS ON. THE PAIN WAS DESCRIBED AS A BEE STING LIKE PAIN AT THE IMPLANT SITE WHICH GOT WORST WHEN THE STIMULATION WAS INCREASED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE IPG AND M8 ADAPTERS WERE REMOVED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2781621 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 359818 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention