BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 11274555 · Received February 3, 2021

    Report

    Report Number
    3006630150-2021-00222
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    January 12, 2021
    Report Date
    February 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8216-50, SERIAL: (B)(4), BATCH: 7071354.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT MIDLINE INCISIONS AND IPG SITE. SYMPTOMS OF SWELLING WAS NOTED. THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169470 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 205673 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention