BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 7929695 · Received October 3, 2018

    Report

    Report Number
    3006630150-2018-61165
    Event Type
    Injury
    Date Received
    October 3, 2018
    Date of Event
    June 1, 2018
    Report Date
    October 26, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8216-50. (B)(4). BATCH/LOT NUMBER: 16954426. MODEL/CATALOG DESCRIPTION: ARTISAN LEAD 50 CM.

    Additional Manufacturer Narrative · 1

    SC-8216-50 (SN: (B)(4)). DEVICE EVALUATION INDICATED THAT THE COMPLAINT WAS NOT VERIFIED. THE LEAD WAS CLEANLY CUT, AND THE PROXIMAL ENDS WERE NOT RETURNED. ALL CABLES WERE EXPOSED BEFORE INTERRING THE PADDLE. THIS DAMAGE WAS SIMILAR TO THE TYPICAL EXPLANT DAMAGE AND WAS NOT CONSIDERED A FAILURE. SC-1160 (SN: (B)(4)). DEVICE EVALUATION INDICATED THAT THE IPG PASSED ALL TESTS PERFORMED.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772689 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 332364 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention