BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 7646206 · Received June 28, 2018

    Report

    Report Number
    3004209178-2018-14565
    Event Type
    Injury
    Date Received
    June 28, 2018
    Date of Event
    June 25, 2018
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO IMDRF HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES NO LONGER APPLY TO THIS EVENT. 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.

    Additional Manufacturer Narrative · 1

    CONTINUATION OF MEDICAL DEVICES: PRODUCT ID 3888-33, LOT# V012744, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. PRODUCT ID 3487A-33, LOT# V013052, PRODUCT TYPE LEAD. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3888-33, SERIAL/LOT #: (B)(4), UBD: 25-SEP-2010, UDI#: (B)(4); PRODUCT ID: 3487A-33, SERIAL/LOT #: (B)(4), UBD: 02-OCT-2010, UDI#: (B)(4). REFLECTS THE OTHER APPLICABLE COMPONENTS CODES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE. IT WAS REPORTED THAT THE HCP DETERMINED THE PATIENT NEED ED NEW LEADS TO COVER HER EXISTING PAIN. CURRENT LEAD IS A 2X4 PADDLE; THEY WERE GOING TO ATTEMPT TO DO SURGERY BEFORE HER INSURANCE CHANGES. NO SURGERY DATE CONFIRMED AT THIS TIME.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA MANUFACTURER'S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL CORD STIMULATION - NONMALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT HAD HER ROUTINE IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT ON (B)(6) 2018. PATIENT WAS TOLD NOT TO USE THE IPG UNTIL SHE SAW HER HEALTHCARE PROVIDER ON (B)(6) 18 FOR DRESSING CHANGE AND TO ENSURE INCISION AT THE IPG POCKET WAS HEALING WELL. THE PATIENT STATE SHE HAD SEEN HER HCP AND HAD STARTED USING HER IPG. PATIENT STATED HER STIMULATION WAS SPOTTY AND COULD NOT GET IT STRONG ENOUGH UNLESS SHE ARCHED HER BACK. REPROGRAMMING WAS DISCUSSED WITH THE PATIENT. PATIENT REPORTED SHE WOULD SEE HER PAIN DOCTOR ON (B)(6). ON (B)(6), THE MANUFACTURER'S REPRESENTATIVE SPOKE WITH PAIN FELLOW REGARDING PATIENT AND CURRENT POOR STIM COVERAGE. FELLOW STATED THAT THE NEXT STEP FOR HER WOULD BE A LEAD REVISION. NO KNOWN ENVIRONMENTAL FACTORS WERE REPORTED. THE IPG IS TO BE REPROGRAMMED TO TRY AND GET BETTER STIM COVERAGE. ISSUE IS NOT RESOLVED AT TIME OF REPORT. SURGICAL INTERVENTION IS UNKNOWN AT THIS TIME. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488185 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 V013052 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention