BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 8426645 · Received March 16, 2019

    Report

    Report Number
    3006630150-2019-01095
    Event Type
    Injury
    Date Received
    March 16, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 30, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-1132, SERIAL/LOT: (B)(4), DESCRIPTION: PRECISION SPECTRA IPG KIT. DEVICE ANALYSIS OF THE LEADS CONFIRMED HIGH IMPEDANCES. ANALYSIS OF SC-2317-70 3120978 REVEALED THAT 15 CABLES WERE FRACTURED ON THE LEAD BODY AT THE KINKED SITE, 24.5 CENTIMETERS AWAY FROM THE DISTAL END WHERE THE CLIK-ANCHOR HAS BEEN PLACED. ANALYSIS OF SC-2317-70 3121311 REVEALED THAT 10 CABLES WERE FRACTURED ON THE LEAD BODY AT THE KINKED SITE, 24.0 CENTIMETERS AWAY FROM THE DISTAL END WHERE THE CLIK-ANCHOR HAS BEEN PLACED. ANALYSIS OF THE IPG REVEALED THAT THE DEVICE COULD NOT BE LINKED NOR CHARGED. AN INTERNAL TEST FOUND EXCESSIVE SLEEP CURRENT DRAINAGE AND HIGH THERMAL. THE DEVICE DAMAGE WAS LIKELY CAUSED BY ELECTROCAUTERY DURING THE LEAD REVISION PROCEDURE.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENTS LEADS WERE EXPLANTED DUE TO HIGH IMPEDANCES. AFTER THE LEADS WERE REPLACED THE IPG FAILED TO WORK. IT WAS REPORTED THAT THE PHYSICIAN USED ELECTROCAUTERY DESPITE BEING WARNED BY THE SALES REPRESENTATIVE. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE. ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF ELECTROCAUTERY. (PHYSICIAN'S IMPLANT MANUAL 90970880-04).

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-2317-70, SERIAL/LOT: (B)(4), DESCRIPTION: INFINION CX LEAD KIT, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCES. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219747 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 19993277 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R