BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 16637050 · Received March 29, 2023

    Report

    Report Number
    3006630150-2023-01634
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    January 2, 2023
    Report Date
    March 29, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED FOUR WEEKS AGO FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL:(B)(4) BATCH: 5043460/7016313.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO LEADS HAVING HIGH IMPEDANCES. IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IPG. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE WAS NOT RELEASED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775913 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 20050813 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention