BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9348591 · Received November 20, 2019

    Report

    Report Number
    3006630150-2019-06673
    Event Type
    Injury
    Date Received
    November 20, 2019
    Date of Event
    September 30, 2019
    Report Date
    November 20, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-8336-50; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 7032013; MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEADS REVELED NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE. SYMPTOMS OF REDNESS AND TENDERNESS WERE NOTED AROUND THE IPG POCKET SITE. THE PATIENT WAS PRECRIBED WITH ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145604 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 343033 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention