BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 8059832 · Received November 12, 2018

    Report

    Report Number
    3004209178-2018-25196
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Report Date
    June 8, 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
    VA, 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. IT WAS REPORTED THAT STARTING OVER A YEAR AGO, THE WIRES IN THE PATIENT'S BACK GOT "ALL MESSED UP." THE PATIENT WAS SUPPOSED TO HAVE SEPARATE PROGRAMS FOR THEIR RIGHT LEG, BACK, AND LEFT LEG, BUT HE COULD ONLY DO ALL AT THE SAME TIME AND NOT SEPARATE LIKE THEY SHOULD BE. THE PATIENT WORKED WITH A REP 2-3 TIMES, BUT SHE COULD NOT GET THE ISSUE FIXED. AS A RESULT, THE PATIENT HASN'T USED OR CHARGED THE DEVICE IN OVER A MONTH. THE PATIENT TRIED RECHARGING ABOUT A WEEK PRIOR TO THE REPORT, BUT THE BATTERY WOULD NOT TAKE A CHARGE. A REPOSITION ANTENNA SCREEN WAS SEEN. NO FURTHER COMPLICATIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

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

    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 A PATIENT IMPLANTED FOR NON-MALIGNANT PAIN. THE PATIENT REPORTED THAT THEY NEEDED ASSISTANCE WITH PUTTING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) INTO MRI MODE. WHILE THE PATIENT WAS ACCESSING MRI MODE AT THE TIME OF THE REPORT, THEY MENTIONED THAT THEY WERE SEEING THE FULL BODY ELIGIBILITY SCREEN. THEY ALSO STATED THAT AFTER ACCESSING MRI MODE, THEY FELT THE STIMULATION IN THEIR FEET AND LEGS. AFTER GIVING IT SOME TIME, THE PATIENT INDICATED THAT THEY NO LONGER FELT THE STIMULATION IN THEIR LEGS BUT DID NOT SPECIFY IF THEY CONTINUED TO FEEL IT IN THEIR FEET. THE PATIENT CONFIRMED THAT THEY ARE HAVING AN MRI TO CHECK ON A PROBLEM WITH THE INS. THEY STATED THAT THEIR BACK IS ¿ALL SCREWED UP, SHATTERED, AND CROOKED.¿ THEY MENTIONED THAT PRIOR TO IMPLANT, THEY WERE OPERATED ON IN 2004, AND THEY ALSO WERE T-BONED IN THEIR DRIVER¿S SIDE DOOR BY AN OAK TREE IN 2010. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT ON (B)(6) 2018 INDICATED THAT AFTER DEACTIVATING MRI MODE, THEY WERE SUCCESSFUL TO TURN ON STIMULATION. HOWEVER, THE PATIENT STATED THAT THEY WERE ON GROUP B AND DID NOT FEEL STIMULATION, AND WANTED TO BE ON GROUP A. THE PATIENT THINKS THAT THEY ACCIDENTALLY SWITCHED TO GROUP A THE DAY PRIOR TO THE REPORT. THEY ADDED THAT THEY HAD ALSO MET WITH A MANUFACTURING REPRESENTATIVE (REP) IN (B)(6) 2018, AND THE REP MESSED WITH IT AND HAD IT ON GROUP A. PATIENT SERVICES WORKED WITH THE PATIENT TO ACTIVATE GROUP A. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT X-RAYS SHOWED THE WIRES WERE IN THE CORRECT POSITION. THE OVERDISCHARGE WAS NOT RESOLVED. THE PATIENT SAID THE PROGRAMMER WAS ONLY WORKING IN ONE POSITION, NOT 3. THE ISSUE WAS NOT RESOLVED DUE TO THE COVID-19 SITUATION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900108 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1