BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6193935 · Received December 21, 2016

    Report

    Report Number
    3007566237-2016-04497
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 30, 2016
    Report Date
    January 31, 2017
    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

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

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3878-75, LOT# 0207489726, IMPLANTED: (B)(6) 2016, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. (B)(6). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER (HCP) REPORTED VIA THE COMPANY REPRESENTATIVE (REP) THAT THE PATIENT WASN¿T FEELING STIMULATION IN THE CORRECT AREA OF THEIR PAIN. THERE WERE NO EXTERNAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO TROUBLESHOOTING/DIAGNOSTICS PERFORMED, ALL IMPEDANCES WERE BETWEEN 989-1200. ACTION TAKEN TO RESOLVE THE EVENT WAS REPROGRAMMING WAS TRIED, BUT THE PATIENT DIDN¿T FEEL STIMULATION WHERE THEY WANTED IT. THE LEAD WAS REPLACED. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. THE PATIENT WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843022 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention