BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9858306 · Received March 20, 2020

    Report

    Report Number
    3006630150-2020-01316
    Event Type
    Injury
    Date Received
    March 20, 2020
    Date of Event
    October 14, 2019
    Report Date
    March 19, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2317-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5071404 / 5074567 / 5075411, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING IRRITATION AND DISCOMFORT AT THE IPG SITE. THE PHYSICIAN BELIEVED THAT THE PATIENT WAS HAVING SOME SORT OF ALLERGIC REACTION TO THE DEVICE AS THE PATIENT HAD ITCHINESS AND RED RASHES IN THE BODY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325610 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 342558 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention