BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10236436 · Received July 6, 2020

    Report

    Report Number
    3006630150-2020-02769
    Event Type
    Injury
    Date Received
    July 6, 2020
    Date of Event
    June 16, 2020
    Report Date
    July 6, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: 5126880/7073045/7073180.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION MAINLY AT THE IPG SITE AND SKIN BREAKAGE AT THE MIDLINE INCISION. SYMPTOMS OF CHILLS AND PAIN WERE NOTED. THE CAUSE OF INFECTION WAS UNKNOWN AND WAS NOT PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN EVERYTHING WAS REMOVED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700658 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 367111 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention