BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 8774198 · Received July 9, 2019

    Report

    Report Number
    3006630150-2019-03417
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    January 1, 2017
    Report Date
    July 9, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANT DATE: 2017. CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-2138-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 151369/153848, MODEL/CATALOG DESCRIPTION: PHASE III LINEAR LEAD - 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566177 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 167902

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention