BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 13981601 · Received April 1, 2022

    Report

    Report Number
    3006630150-2022-01407
    Event Type
    Injury
    Date Received
    April 1, 2022
    Date of Event
    February 10, 2019
    Report Date
    April 1, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    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

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED FEW YEARS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2138700, MODEL: SC-2138-70, SERIAL: (B)(4), BATCH: A30697/151404.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IPG WAS NOT WORKING AND UNABLE TO CHARGE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED SCS SYSTEM WAS NOT RETURNED AS IT WAS NOT RELEASED FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329649 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 171863

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention