BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 10096216 · Received May 28, 2020

    Report

    Report Number
    3004209178-2020-09284
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Report Date
    December 3, 2020
    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
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT WHO REPORTED THAT IT IS WORSE, AND SHE CANNOT TURN STIMULATION OFF. THE PATIENT PROGRAMMER SHOWED THAT STIMULATION WAS OFF, AND THE PATIENT WASN'T SEEING LIGHTNING BOLTS TO INDICATE THAT STIMULATION WAS TURNED ON. THE PATIENT WAS STILL FEELING STIMULATION. THE PATIENT NOTED THAT SHE HAD A COUPLE OF MRIS AND A YEAR AGO, SHE HAD A SURGERY TO REMOVE A CYST FROM HER SPINE. THE PATIENT WAS REDIRECTED TO THEIR HEALTH CARE PROFESSIONAL.

    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 CONSUMER REGARDING TWO IMPLANTABLE NEUROSTIMULATORS (INS) FOR NON-MALIGNANT PAIN AND SPINAL PAIN. IT WAS REPORTED THAT PROBABLY A YEAR AGO THE PATIENT NOTICED THAT EVERY ONCE IN A WHILE THEY WOULD CONTINUE TO FEEL STIMULATION AT THE SAME AMPLITUDE EVEN AFTER DECREASING IT. THE PATIENT EXPLAINED THAT THEY LOWER THE STIMULATION AT NIGHT, BUT IT WOULD FEEL LIKE THE SAME STIMULATION RATHER THAN LOWERING A COUPLE OF TIMES. THEY SAID IT WOULD EVENTUALLY CALM DOWN. THE PATIENT THEN SAID THAT ON (B)(6) 2020 THEY FELT AN UNCOMFORTABLE STIMULATION IN THEIR FEET AND CAN¿T GET THEM TO STOP VIBRATING. THEY NOTICED THIS SHORTLY AFTER SYNCING THE INS WITH THEIR PROGRAMMER. THE PATIENT TURNED BOTH INS¿S OFF AND DECREASED THE AMPLITUDE TO 0V ON ALL PROGRAMS. THE PATIENT CHECKED TO SEE IF THE INS¿S WERE OFF AND THEY WERE, AND NO PROGRAMS WERE SELECTED. THEY NOTICED THAT THE AMPLITUDE WAS NOT SET TO 0V FOR ALL PROGRAMS. THE PATIENT CHARGED THE AMPLITUDES TO 0V AND WILL MONITOR SYMPTOMS AND FOLLOW UP WITH THEIR HEALTHCARE PROVIDER (HCP). NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562998 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1