BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 21921529 · Received April 28, 2025

    Report

    Report Number
    3004209178-2025-07325
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Report Date
    May 28, 2025
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: 3888-45, LOT# V250887, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(6), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. 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

    B3: EVENT DATE IS NOT KNOWN. PLEASE SEE B5 FOR APPROXIMATE DATE RANGE, IF APPLICABLE. SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME PISCES-QUAD; PRODUCT ID 3888-45 (LOT: V250887); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2009 BRAND NAME ; PRODUCT ID 3778-45 (SERIAL: (B)(6); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2009 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

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE CAUSE WAS UNKNOWN. THEY WERE TOLD TO STOP USING THE STIMULATION AND THE ISSUE WAS NOT RESOLVED.

    Description of Event or Problem · 0

    THE REASON FOR CALL WAS PT STATED THAT A LITTLE WHILE AFTER THEY WERE IMPLANTED WITH THE DEVICE, THEY WENT TO USE IT AND IT BURNED FROM THE INSIDE WHEN THEY WERE TRYING TO USE STIMULATION. CALLER CLARIFIED THAT IT FELT LIKE THE WIRES INSIDE WERE BURNING. CALLER STATED SHE TALKED TO THE HCP AT THE TIME AND HE TOLD PT TO STOP USING THE DEVICE. THE PATIENT DISCUSSED THE POSSIBILITY OF REMOVING THE NEUROSTIMULATOR WITH THE HEALTHCARE PROVIDER, WHO SUGGESTED LEAVING IT IMPLANTED. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581199 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female