BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 9463349 · Received December 12, 2019

    Report

    Report Number
    3004209178-2019-23731
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Report Date
    December 12, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE PATIENT VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FAILED BACK SURGERY SYNDROME AND SPINAL PAIN. IT WAS REPORTED APPROXIMATELY IN THE BEGINNING OF 2019, THE PATIENT FELL AND SINCE THE FALL THEY HAD BEEN EXPERIENCING MORE PAIN IN THEIR LEFT LEG. THEY STATED THAT ABOUT A MONTH AGO THEY HIT THEIR BATTERY ON A CHAIR AND A CLINICAL SPECIALIST CHECKED IMPEDANCES AND ALL WERE WITHIN NORMAL LIMITS. THE PATIENT¿S USAGE IN THE LAST 30 DAYS WAS ONLY MINIMAL IN THE LAST 7 DAYS. THE PATIENT STATED THAT THEY FELT LIKE THE TINGLING MADE THEIR PAIN MORE IRRITABLE. THE PATIENT WAS GIVEN A NEW PROGRAM AND THEY FELT STIMULATION WHERE THEY NEEDED WHEN IT WAS TESTED. THE PROGRAM WAS THEN MADE INTO A HIGH-DENSITY PROGRAM USING 90/1000. THE PATIENT DENIED ALL OTHER COMPLAINTS AT THIS TIME. THE PATIENT WAS SEEING THEIR DOCTOR TODAY AND THE DOCTOR WAS MADE AWARE OF THE PATIENT¿S ISSUE AND CHANGES. IT WAS INDICATED THAT A FALL MAY HAVE CONTRIBUTED TO THEIR ISSUE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE EVENT DATE WAS ASKED BUT WAS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250370 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1