BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 9617780 · Received January 22, 2020

    Report

    Report Number
    3004209178-2020-01592
    Event Type
    Injury
    Date Received
    January 22, 2020
    Date of Event
    December 5, 2019
    Report Date
    March 26, 2020
    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
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE (B)(4) APPLIES TO THE IMPLANTABLE NEUROSTIMULATOR, 97715, S/N (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-30, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 97745, SERIAL#: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 97745, SERIAL# (B)(4). PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE LEAD, PRODUCT ID 97745, SERIAL# UNKNOWN. PRODUCT TYPE PROGRAMMER, PATIENT. 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REPORTING THAT THE LEADS NOT WORKING WAS A DEVICE ISSUE AND THE MANUFACTURER REPRESENTATIVE (REP) WOULD BE THE CONTACT FOR FURTHER DETAILS REGARDING THE CAUSE. THE LEADS WILL NOT BE RETURNED FOR ANALYSIS, AND THE REPLACEMENT OF THE LEADS RESOLVED THE PATIENT'S REPORTED ISSUES. THE PATIENT WAS (B)(6) AT THE TIME OF THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR (INS). CONSUMER REPORTED THEY TRIED TO INCREASE STIMULATION BUT THE CONTROLLER SHOWED "UPPER LIMIT REACHED" AND THEY WERE NOT BE ABLE TO ADJUST STIM. THIS HAD BEEN OCCURRING INTERMITTENTLY AND WHILE ON THE CALL THEY WERE ABLE TO INCREASE STIM TO 6.4 BUT PRIOR TO THE CALL WERE NOT ABLE TO INCREASE. PATIENT REPORTED THEY WERE NOT ABLE TO GET STIM INCREASED ENOUGH OR IN THE RIGHT SPOT. IT WAS REPORTED THAT THE LEADS WERE NOT WORKING AND THEY WERE NOT ABLE TO GET THE STIMULATION TO HELP WITH THE THERAPY. IT WAS REPORTED THAT THIS HAS OCCURRED SINCE IMPLANT. REPROGRAMMING DID NOT RESOLVE THE ISSUE. THE PATIENT WAS SENT A NEW CONTROLLER AS THE OLD ONE¿S BUTTONS WOULDN¿T ALWAYS WORK HOWEVER THE NEW CONTROLLER WOULD NOT POWER ON. THEY HAD NOT PUT THE LITHIUM BATTERY PACK INTO IT YET. IT WAS LATER REPORTED THAT THE PATIENT WAS TRYING TO TURN THEIR INS ON AND SAW THE SETTINGS NOT AVAILABLE SCREEN ON THEIR CONTROLLER. THEIR INS WAS CURRENTLY CHARGED TO 40%. THEY ONLY HAVE 1 GROUP AVAILABLE. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. PATIENT REPORTED THEY ARE NERVOUS THAT THEY WILL HAVE TO HAVE THE DEVICE REMOVED IF THE LEADS ARE NOT WORKING. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE CAUSE OF THE LEADS NOT WORKING WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT WOULD BE MEETING WITH HER DOCTOR NOW THAT THE LEADS WERE OUT TO DISCUSS NEXT STEPS. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78643 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention