BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9412722 · Received December 4, 2019

    Report

    Report Number
    3006630150-2019-07073
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    July 18, 2019
    Report Date
    December 4, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5148213/5150200, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEADS REVEALED THAT 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 HAD AN ALLERGIC REACTION FROM THE SPINAL CORD STIMULATOR (SCS) AND DEVELOPED AN INFECTION. SYMPTOM OF SEVERE ITCHINESS ALL OVER THE PATIENTS BODY WAS NOTED. IT WAS ALSO REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE COVERAGE DUE TO THE LEAD PLACEMENT. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208590 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 356089 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention