BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 21846228 · Received April 16, 2025

    Report

    Report Number
    3004209178-2025-06543
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 25, 2025
    Report Date
    May 28, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Removal / Correction Number
    Z-1535-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS APPROXIMATE. MONTH AND YEAR CONFIRMED AS VALID. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 97755, SERIAL#: (B)(6), UDI#: (B)(4); PRODUCT TYPE RECHARGER. 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.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ID 97755 SERIAL# (B)(6): PRODUCT TYPE RECHARGER WAS RETURNED AND THE ANALYSIS SHOWS SCRAPPED DUE TO LOW READING BEING 0 SHOULD BE HIGHER THAN 30. 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 PATIENT (PT) REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS PATIENT MENTIONED THAT THE RECHARGER IS NOT CHARGING THE IMPLANTED NEUROSTIMULATOR VERY WELL AT ALL. PATIENT MENTIONED THAT RIGHT WHERE THE WIRE GOES INTO THE BACK OF THE UNIT, RECHARGER CORD GETS REALLY HOT. PATIENT ALSO MENTIONED THAT LAST NIGHT THEY HAD IT ON FOR 45 MINUTES TO GO FROM 80% TO 90% AND NOTICED THAT THE WIRE HAS BEEN GETTING HOT MORE AND MORE. PATIENT MENTIONED THAT THIS STARTED PROBABLY A COUPLE WEEKS AGO, THEY THOUGHT IT WAS A LITTLE WARM BUT LAST NIGHT AFTER THAT LONG CHARGE PERIOD, THEY NOTICED THE WIRE WAS WARM. PATIENT THEN MENTIONED THE CORD IS KIND OF FRAYED. A REQUEST WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE RECHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349999 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male "SEE H11....".