BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 8515298 · Received April 15, 2019

    Report

    Report Number
    3006630150-2019-01666
    Event Type
    Injury
    Date Received
    April 15, 2019
    Date of Event
    March 20, 2019
    Report Date
    May 15, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE IPG INCISION SITE AS OZZING WAS NOTICED FROM IT. THE PHYSICIAN STATED THAT THE IPG AND LEAD WAS INFECTED. THE PATIENT WAS PUT ON ANTIBIOTICS AND IT WAS NOTED THAT THE IPG SITE WAS NOT OOZING.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8336-50, SERIAL/BATCH/LOT NUMBER: (B)(4), MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE IPG INCISION SITE AS OOZING WAS NOTICED FROM IT. THE PHYSICIAN STATED THAT THE IPG AND LEAD WAS INFECTED. THE PATIENT WAS PUT ON ANTIBIOTICS AND IT WAS NOTED THAT THE IPG SITE WAS NOT OOZING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307745 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 20802719 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention