BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 7496668 · Received May 8, 2018

    Report

    Report Number
    3004209178-2018-10413
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 15, 2018
    Report Date
    August 24, 2018
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. 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 MANUFACTURING REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PATIENT WAS HAVING RADIATION TREATMENT DONE FOR CANCER IN GROIN AREA. REP STATED THEY WERE NOTIFIED AUG 14,2018 THAT PATIENT HAD ANOTHER POWER ON RESET (POR). REP SAW THE PATIENT YESTERDAY AND CLEARED IT. PATIENT CONFIRMED WITH THE PATIENT PROGRAMMER THAT POR WAS CLEARED AND EVERYTHING WAS FINE. REP RECEIVED ANOTHER CALL TODAY (B)(6) 2018 THAT PATIENT WAS SEEING ANOTHER POR BUT THEY HAD NOT HAD ANOTHER TREATMENT SINCE THEY HAD THE LAST POR CLEARED. REP DID NOT KNOW IF THE PATIENT HAD COME INTO CONTACT WITH ANOTHER SOURCE OF EMI. REP IS GOING TO TRY MEET WITH THE PATIENT TOMORROW ((B)(6) 2018). ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP).IT WAS REPORTED THAT REP WANTED TO UNDERSTAND THE MEANING BEHIND 0X400 POWER ON RESET (POR) CODE FROM THE CLINICIAN PROGRAMMER. REP ALSO WANTED TO UNDERSTAND IF RADIATION THERAPY THAT TRIGGERED A POR WHICH WAS CLEARED, COULD CONTINUE TO CAUSE PORS. REP WANTED INSTRUCTIONS ON HOW TO CLEAR INFORMATIONAL POR WITH PATIENT PROGRAMMER. INSTRUCTIONS TO CLEAR INFORMATIONAL POR WERE REVIEWED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.

    Additional Manufacturer Narrative · 1

    DATE INACCURATE, ONLY THE MONTH AND YEAR ARE VALID. 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 MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT A WARNING POWER ON RESET (POR) MESSAGE WAS SEEN A COUPLE OF WEEKS AGO. WHEN ASKED IF THE PATIENT HAD ANY RECENT MEDICAL TESTS OR EMI ENVIRONMENTAL EXPOSURE THE REPRESENTATIVE REPORTED THAT THE PATIENT HAD RADIATION TREATMENT. THE PATIENT WAS REDIRECTED TO SEE THEIR HEALTHCARE PROVIDER TO ADDRESS THE POR MESSAGE. NO FURTHER COMPLICATIONS REPORTED. (B)(6) 2018. NO NEW INFORMATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE. IT WAS REPORTED THAT THE POR HAD BEEN RESOLVED AND THE CLINICIAN PROGRAMMER WAS USED TO RESOLVE THE POR. THE PATIENT'S WEIGHT WAS UNKNOWN. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337371 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR