BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9342175 · Received November 19, 2019

    Report

    Report Number
    3006630150-2019-06641
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    October 9, 2019
    Report Date
    November 19, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8336-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7042567, MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS AND IPG REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATE TO THE EVENT OCCURRED DURING THE MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED VIA SOCIAL MEDIA THAT THE PATIENTS SCS WAS CAUSING HIS PAIN TO INTENSIFY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134241 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 348973 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention