BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 16697319 · Received April 6, 2023

    Report

    Report Number
    3006630150-2023-01851
    Event Type
    Injury
    Date Received
    April 6, 2023
    Date of Event
    January 17, 2023
    Report Date
    April 6, 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
    CT, 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)(4), BATCH: 282212 / 113869.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO HIGH IMPEDANCES. THE PATIENT ALSO HAD A DIFFICULTY CHARGING THE IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549196 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 20907390 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention