BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 8151004 · Received December 11, 2018

    Report

    Report Number
    3004209178-2018-27358
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    September 1, 2018
    Report Date
    February 8, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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 THE CIRCUMSTANCES THAT LED TO THE ISSUE WERE THAT THE PATIENT WAS LYING IN BED. THE BATTERY HAD BEEN FULLY CHARGED MANY HOURS EARLIER AND IT STARTED TO BURN. THIS LASTED FOR 2 HOURS. THE PATIENT TURNED IT OFF, CHANGED POSITIONS, STOOD AND WALKED, BUT NOTHING HELPED. AT ONE POINT, SITTING AT THE EDGE OF THE BED LESSENED THE PAIN FOR A LITTLE WHILE. THE ISSUE FINALLY STOPPED. THE PATIENT SAID THE ISSUE HAS NOT REOCCURRED AS BAD AS IT DID IN DECEMBER 2018. IT STARTED TO BURN A LITTLE ONE NIGHT LAST WEEK WHEN THE PATIENT WAS LYING IN BED ON THEIR LEFT HIP (THE BATTERY SIDE). THE PATIENT TURNED STIM OFF AND THE BURNING STOPPED. NO FURTHER COMPLICATIONS WERE REPORTED.

    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 FAMILY MEMBER OF A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ON/OFF BURNING AND STINGING UNDER THE IMPLANTABLE NEUROSTIMULATOR (INS). IT GOT VERY HOT WITH BURNING WHICH STARTED ON THE DAY PRIOR TO THE REPORT ABOUT 4 HOURS AFTER THE PATIENT CHARGED HER INS. THE CALLER SAID IT BURNED FOR A LONG TIME AND IT MADE NO DIFFERENCE IT THE INS WAS ON OR OFF. THEN, THE PATIENT TOOK PAIN PILLS AND WHEN SHE WOKE UP ON THE MORNING OF THE REPORT, IT WAS BETTER BUT STILL BURNED A LITTLE BIT. THE CALLER NOTED THAT THESE ISSUES STARTED AFTER THE PATIENT HAD GALLBLADDER SURGERY AND HAD HAPPENED NUMEROUS TIMES. LASTLY, WHEN ASKED IF THE PATIENT HAD ANY RECENT MEDICAL TEST OR EMI ENVIRONMENTAL EXPOSURE, IT WAS REPORTED THAT THE PATIENT HAD HER NERVES BURNED FOR THE PAIN THE INS WAS NOT SET UP TO HELP WITH. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992886 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR