BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 18265983 · Received December 5, 2023

    Report

    Report Number
    3006630150-2023-07610
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    August 4, 2023
    Report Date
    December 5, 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
    NY, US
    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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7102155/7102376.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT COULD NOT CHARGE DUE TO SWELLING. THE PHYSICIAN BELIEVED THAT SWELLING WAS NORMAL. THE PATIENTS LEADS HAD MIGRATED AND WAS CONFIRMED THROUGH AN X RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235260 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 207557 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention