BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA

    MDR report key: 7557123 · Received May 31, 2018

    Report

    Report Number
    3006630150-2018-01937
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    May 11, 2018
    Report Date
    July 3, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729779902
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SC-8216-50 (B)(4) DEVICE EVALUATION INDICATED THAT THE COMPLAINT WAS CONFIRMED. SIX CABLES (E1, E2, E3, E4, E8 AND E13) WERE FRACTURED ON THE LEAD BODY AT THE KINK SECTION WHERE THE CLIK-ANCHOR WAS POSITIONED. FRACTURE LOCATION IS 1 CM FROM THE CLIK ANCHOR SET SCREW MARK. NO CABLES WERE EXPOSED AT THE SITE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO CONTACTS OUT ON THE LEAD. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO CONTACTS OUT ON THE LEAD. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400844 PRECISION SPECTRA SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA 08714729779902

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR