BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10420564 · Received August 18, 2020

    Report

    Report Number
    3006630150-2020-03475
    Event Type
    Injury
    Date Received
    August 18, 2020
    Date of Event
    July 23, 2020
    Report Date
    August 18, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7072315 / 7072545.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A STAPHYLOCOCCUS AUREUS INFECTION. SYMPTOMS AND LOCATION OF INFECTION WERE UNKNOWN. IT WAS ALSO UNKNOWN IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED AS WELL AS THE CAUSE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL DEVICE COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886168 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 366857 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention