BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 7703055 · Received July 19, 2018

    Report

    Report Number
    3004209178-2018-16168
    Event Type
    Injury
    Date Received
    July 19, 2018
    Date of Event
    July 1, 2018
    Report Date
    October 2, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 HCP. IT WAS REPORTED THAT PATIENT WAS HAVING AN MRI WHICH RELATED TO THE DEVICES BECAUSE THE PATIENT HAD A BATTERY CHANGE AND THEN HAD SOME ISSUES. THE CALLER DOES NOT KNOW WHAT THE ISSUES ARE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION. 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 REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL TO ADDRESS THE INS POCKET DRAINING FLUID. THE DOCTOR ADDRESSED THE ISSUE BY WASHING AND DRAINING THE POCKET. IT WAS ALSO REPORTED THAT THE PATIENT WAS HAVING A COMMUNICATION ISSUE USING THE CONTROLLER. IT WAS REPORTED THAT THE PATIENT HAS NOT CHARGED BECAUSE OF HOSPITALIZATION AND SUBSEQUENTLY SAW A ¿CAN'T FIND DEVICE SCREEN¿ ON THE CONTROLLER WHEN TRYING TO CHARGE THE INS. THE MANUFACTURER REPRESENTATIVE SUSPECTED THAT THE PATIENT¿S INS WAS FULLY DISCHARGED. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) ON 2018-JUL-27. THERE WAS AN OPEN WOUND OVER THE BATTERY BEGINNING ON AN UNKNOWN DAY IN (B)(6) 2018. THE WOUND WAS DRAINING A CLEAR FLUID AND THERE WAS A SMALL OPENING IN THE INCISION. AN EXAM WAS DONE. THE REP STATED THAT THE CAUSE WAS DUE TO THE PATIENT HAVING A RECENT BATTERY REVISION. THE PATIENT WOULD BE GOING TO SURGERY ON (B)(6) 2018 FOR A REVISION OF THE WOUND. THE ISSUE WAS NOT YET RESOLVED BUT THE PATIENT WAS NOTED TO BE ALIVE WITH NO INJURY. THE REP WOULD OBTAIN ADDITIONAL INFORMATION FROM THE HEALTHCARE PROFESSIONAL (HCP) ON 2018-JUL-31. IT WAS NOTED THAT THE PATENT¿S MEDICAL HISTORY INCLUDES MULTIPLE BACK SURGERIES. NO FURTHER COMPLICATIONS WERE REPORTED/ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545718 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R