BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8769419 · Received July 8, 2019

    Report

    Report Number
    3006630150-2019-03382
    Event Type
    Injury
    Date Received
    July 8, 2019
    Date of Event
    June 7, 2019
    Report Date
    August 16, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-1160, SN (B)(4): DEVICE EVALUATION INDICATED THAT THE DEVICE PASSED ALL TESTS PERFORMED. SC-8336-50, SN (B)(4): DEVICE EVALUATION INDICATED THAT VISUAL INSPECTION FOUND THE LEAD WAS CLEANLY CUT AND DAMAGE WAS SIMILAR TO THE TYPICAL EXPLANT DAMAGE.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8336-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 21420486, MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560635 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 330961 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention