BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8968499 · Received September 6, 2019

    Report

    Report Number
    3006630150-2019-04873
    Event Type
    Injury
    Date Received
    September 6, 2019
    Date of Event
    August 19, 2019
    Report Date
    September 6, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5152334/5153741, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. 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. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WERE FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE. IT WAS REPORTED THAT THE PATIENT WAS A HEAVY SMOKER AND DIABETIC. IT WAS MENTIONED THAT PATIENT WAS NOT TAKING HER DIABETIC MEDICATION WHEN IT WAS CHANGED DURING OR RIGHT AFTER THE IMPLANT PROCEDURE WHICH PHYSICIAN BELIEVED THAT MIGHT CONTRIBUTED TO THE INFECTION. THE PHYSICIAN BELIEVED THAT INFECTION WAS NOT DEVICE RELATED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762816 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 353903 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention