BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 18271587 · Received December 5, 2023

    Report

    Report Number
    3006630150-2023-07631
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    November 10, 2023
    Report Date
    December 5, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: AVISTA MRI, UPN: M365SC2408740, MODEL: SC-2408-74, SERIAL: (B)(6), BATCH: 5032351.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE OF THE SCS SPINAL CORD STIMULATOR (SCS). IT WAS NOTED THAT THERE WAS PUS SECRETING FROM THE IPG INCISION SITE. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE IPG AND ONE OF THE FOUR IMPLANTED LEADS WAS EXPLANTED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233213 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 20686851 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention