BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 19669366 · Received July 3, 2024

    Report

    Report Number
    3004209178-2024-14138
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 3, 2023
    Report Date
    July 3, 2024
    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
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS CALLER REPORTS SHE IS MEETING WITH PATIENT TODAY. CALLER REPORTS PATIENT INDICATED SHE IS HAVING TO CHARGE EVERY DAY, WHICH SHE DID NOT THINK WAS RIGHT. CALLER REPORTS PATIENT IS CHARGING WITH EXCELLENT QUALITY, USING THE RECHARGING BELT. CALLER REPORTS PATIENT'S DEVICE HAS BEEN DEAD FOR THE PAST 3-4 MONTHS. REVIEWED PASSIVE RECHARGE MODE. CALLER REPORTS PATIENT IS NOW CHARGING WITH EXCELLENT. CONTROLLER IS 100% CHARGED AND INS IS IN THE RED BATTERY. SUGGEST CONTINUING TO CHARGE THE INS. SUGGEST INTERROGATING INS AFTER CHARGING THE INS, ASSESSING THE RECHARGING DIARY, LOOKING AT THE COUPLING AND WHAT PERCENTAGE PATIENT ENDED HER CHARGE. SUGGEST LO OKING AT THE RECHARGING INTERVAL CALCULATION. ADDITIONAL INFORMATION FROM THE PATIENT INDICATED THAT IT TOOK 2-4 HOURS TO CHARGE DAILY. THE DEVICE WAS REPLACED IN (B)(6) 2024. ISSUE WAS RESOLVED. PATIENT WEIGHT IS 170LBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434654 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention