BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8116376 · Received November 29, 2018

    Report

    Report Number
    3006630150-2018-62014
    Event Type
    Injury
    Date Received
    November 29, 2018
    Date of Event
    November 8, 2018
    Report Date
    November 29, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8336-70 , SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7022599, MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL COMPLAINING OF WEAKNESS AND NUMBNESS IN THE LEGS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953937 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 338854 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R