BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11153928 · Received January 12, 2021

    Report

    Report Number
    3006630150-2020-06667
    Event Type
    Injury
    Date Received
    January 12, 2021
    Date of Event
    December 21, 2020
    Report Date
    February 2, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE. THE PHYSICIAN BELIEVES THE INFECTION WAS NOT DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND PUS WERE NOTICED DURING SURGERY. THE PATIENT WAS DOING WELL POSTOPERATIVELY. EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS PLACED AN ANTIBIOTICS.

    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-2317-50, SERIAL: (B)(4), BATCH: 7072865/7073073.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE. THE PHYSICIAN BELIEVES THE INFECTION WAS NOT DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND PUS WERE NOTICED DURING SURGERY. THE PATIENT WAS DOING WELL POSTOPERATIVELY. EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53499 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 373476 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention