BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 23181469 · Received September 30, 2025

    Report

    Report Number
    3004209178-2025-16509
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Report Date
    September 30, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME: PISCES Z QUAD; PRODUCT ID: 389033 (LOT: V000908); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE: ON (B)(6) 2006. 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

    THE REASON FOR CALL WAS CALLER REPORTED THEY HAD A FALL THEY THINK IN 2015 OR 2016 AND "IT" WASN'T WORKING WELL SO THEY MET WITH AN MDT REP (NAME ASKED/UNKNOWN) AND WERE TOLD THAT ONE OF THE LEADS HAD DISCONNECTED. PATIENT STATED THEY DON'T NEED THE SCS DEVICE ANYMORE BECAUSE THEY DON'T HAVE ANYMORE SCIATICA OR WHATEVER, BUT THEY ARE CURRENTLY GOING THROUGH BREAST CANCER TREATMENT AND ARE SCHEDULED FOR A BILATERAL MASTECTOMY AND THEN WILL BE HAVING AN MRI EVERY COUPLE OF YEARS. PATIENT STATED THEY KNOW THEY ARE NOT ELIGIBLE FOR A FULL BODY MRI AND INQUIRED AS TO WHETHER REMOVING THE INS WOULD ALLOW FOR THIS. AGENT REVIEWED INFORMATION REGARDING LEADS AND REDIRECTED TO HCP TO DISCUSS POSSIBILITY OF FULL SYSTEM REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2214946 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO JUNCOS 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SEE H11.