BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 6091647 · Received November 9, 2016

    Report

    Report Number
    9614453-2016-06696
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 19, 2016
    Report Date
    November 9, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A275, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL, VIA A MANUFACTURER REPRESENTATIVE, REPORTED A PATIENT HAD A LEAD IMPLANTED FOR A TEST TRIAL FOR ONE WEEK WITH GOOD RESULTS. THE LEAD WAS CONNECTED TO AN IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2016 AND, WHEN THE PATIENT'S STIMULATION WAS TURNED ON POST-OP, ALL ELECTRODES SHOWED AN IMPEDANCE GREATER THAN 10,000 OHMS (HIGH IMPEDANCE). THERE WAS NO PARESTHESIA. THE PATIENT WAS TAKEN INTO THE OPERATING ROOM AGAIN. WHEN TESTING WITH THE MULTI-LEAD TRIALING CABLE, ALL ELECTRODE IMPEDANCES WERE FINE. CHANNEL TWO OF THE INS HAD TO BE USED INSTEAD OF CHANNEL ONE. THEN, ALL ELECTRODE IMPEDANCES WERE AROUND 1200 OHMS. THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740073 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention