BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8654874 · Received May 30, 2019

    Report

    Report Number
    3006630150-2019-02543
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    May 8, 2019
    Report Date
    October 12, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED IPG (SC-1160 SN: (B)(6)) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD PAIN AT THE POCKET SITE WHICH WAS SEVERE. THE PATIENT WAS POSITIVE FOR INFECTION AND UNDERWENT AN EXPLANT PROCEDURE. THIS WAS NOT PROCEDURE AND DEVICE RELATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8336-50; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 7031233; MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING THE 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 HAD PAIN AT THE POCKET SITE WHICH WAS SEVERE. THE PATIENT WAS POSITIVE FOR INFECTION AND UNDERWENT AN EXPLANT PROCEDURE. THIS WAS NOT PROCEDURE AND DEVICE RELATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447644 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 350114 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention