BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 19774606 · Received July 18, 2024

    Report

    Report Number
    3004209178-2024-15038
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 18, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT THIS MORNING THEY STARTED SEEING A POR (POWER ON RESET) MESSAGE ON THEIR RECHARGER WITH A CAUTION SIGN. CALLER STATED THEY COULDN'T SEEM TO CLEAR THE MESSAGE. AGENT HAD CALLER CONNECT THE PROGRAMMER TO THE IMPLANT. CALLER CONFIRMED SEEING THE INFORMATIONAL POR MESSAGE ON THE PROGRAMMER. AGENT WALKED CALLER THROUGH CLEARING THE POR MESSAGE. CALLER CONFIRMED THE POR POWER ON RESET MESSAGE CLEARED, AND THEY WERE ABLE TO ACCESS THE THERAPY SCREEN. AGENT REVIEWED WITH CALLER EVERYTHING APPEARS TO BE WORKING AS INTENDED AND INSTRUCTED TO MONITOR THE ISSUE AND CALL BACK IF IT PERSISTS. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918298 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female