BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 18263592 · Received December 4, 2023

    Report

    Report Number
    3006630150-2023-07595
    Event Type
    Injury
    Date Received
    December 4, 2023
    Date of Event
    November 7, 2021
    Report Date
    December 4, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: COVEREDGE X 32, UPN: M365SC8352700, MODEL: SC-8352-70. SERIAL: (B)(6), BATCH: 21349449. BRAND NAME: NULL, UPN: M365SC3354250, MODEL: SC-3354-25, SERIAL: (B)(6), BATCH: 7070019. BRAND NAME: LINEAR 3-6, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 7070834 AND 7071876.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOR APPROXIMATELY THE PAST TWO YEARS, THE PATIENT WAS SLOWLY EXPERIENCING THE SPINAL CORD STIMULATION SYSTEM TO BE LESS EFFECTIVE. THE PHYSICIAN ASSESSED THIS WAS PROBABLY DUE TO THE PATIENTS DETERIORATING BACK. THE PATIENTS SYSTEM WAS REPROGRAMMED HOWEVER THE ISSUE PERSISTED. THE PATIENT UNDERWENT AN EXPLANT OF THE ENTIRE SYSTEM AND IS RECOVERING WITHOUT ISSUE. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160746 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 20207882 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention