BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 12545521 · Received September 29, 2021

    Report

    Report Number
    3004209178-2021-14550
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    September 20, 2021
    Report Date
    November 4, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315467
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 MANUFACTURING REPRESENTATIVE (REP) AND IT WAS REPORTED THAT THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE INS WAS REPROGRAMED AND THE ISSUE WAS RESOLVED. EMI WAS NOT CONFIRMED.

    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 WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. PATIENT MENTIONED THEIR INTENSITY SETTINGS ON THEIR THERAPY WERE GOING DOWN TO "0" BY THEMSELVES WITHOUT PROMPTING FROM THE PT SINCE MONDAY. PT SAID THEY HURT FROM "HIPS TO HEALS" TODAY, AND PT SAID THEY WERE IN PAIN BECAUSE THE INTENSITY SETTING KEPT ADJUSTING TO "0." DURING THE CALL, PT WAS ON GROUP B AND HAD PROGRAM 1 AND 2. ADAPTIVE STIMULATION WAS ACTIVE IN PROGRAM 1, AND PATIENT SERVICES SPECIALIST(PSS) DESCRIBED THE FUNCTION OF ADAPTIVE STIMULATION. PT SAID THEY DO NOT THINK ADAPTIVE STIMULATION WAS CAUSING INTENSITY SETTINGS TO ADJUST TO "0" AND INTENSITY SETTINGS HAD "NEVER GONE TO 0" BEFORE. PT TYPICAL INTENSITY SETTINGS WERE 9 ON THE LEFT SIDE AND 10 ON THE RIGHT SIDE. PT HAD MET WITH A MANUFACTURER REPRESENTATIVE LAST WEEK FRIDAY, BUT HAD NOT INFORMED THEIR REP OF THE INTENSITY SETTING ISSUE YET. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PT MENTIONED THEY HAD A "LIVE WIRE" IN THEIR GARAGE SHOCK AND ASKED WHETHER OR NOT THIS SHOCK FROM THE LIVE WIRE COULD HAVE IMPACTED THE THERAPY FROM THE SPINAL CORD STIMULATOR. PSS SUGGESTED THE PT MENTION THE SHOCK FROM THE LIVE WIRE TO THEIR HCP AND FOLLOW UP WITH THE REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446071 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male