BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 5963474 · Received September 20, 2016

    Report

    Report Number
    3007566237-2016-03313
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Date of Event
    August 29, 2016
    Report Date
    November 4, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES: THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. REPORT SOURCE: (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_STYLET_ACC, PRODUCT TYPE: ACCESSORY. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS FOR LEAD (B)(4) REVEALED NO ANOMALY FOUND. CONCLUSION CODE BELONGS TO LEAD (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED VIA A COMPANY REPRESENTATIVE (REP) REGARDING AN TRIAL IMPLANT PROCEDURE. THE SECOND ELECTRODE WAS IMPLANTED AND THE POSITION WAS VERIFIED WITH FLUOROSCOPY. THE CLINICIAN PROGRAMMER INITIATED THE SPINAL STIMULATION WITH A FREQUENCY OF 80 HZ, A PULSE WIDTH OF 420 MSEC, AND AN AMPLITUDE OF 1 VOLT TO 4.5 VOLTS. HOWEVER, THE PATIENT DID NOT FEEL THE STIMULATION DESPITE THE HIGH PARAMETERS. THE DOCTOR DECIDED TO CHANGE THE ELECTRODE. THE NEW ELECTRODE WAS POSITIONED UNDER FLUOROSCOPY. THE ELECTRODE WAS PROGRAMMED WITH A FREQUENCY OF 80 HZ, A PULSE WIDTH OF 380 MSEC AND AN AMPLITUDE OF 0.5 VOLTS AND THE ISSUE RESOLVED. THE PATIENT WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616086 EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR