BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 15880068 · Received November 29, 2022

    Report

    Report Number
    3004209178-2022-15642
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Date of Event
    October 1, 2022
    Report Date
    November 29, 2022
    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
    MI, 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

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. THE CALLER STATED THAT IN OCTOBER THEY STARTED TO NOTICE THAT USUALLY IN THE MORNINGS WHEN THEY STAND UP THEY GET AN EXTREME SHOCK SENSATION DOWN THEIR LEG AND IN THEIR BACK. CALLER STATED IT FEELS LIKE THEIR SCIATIC NERVE LOCKS UP AND HURTS SO BAD IT TAKES THEIR BREATH AWAY. CALLER ADDED IT HAPPENS MOSTLY IN THE MORNINGS WHEN THEY'RE STANDING UP OR IF THEY'RE LAYING IN BED AND ROLL OVER OR STRETCH. CALLER ADDED THAT THERE IS A RESIDUAL PAIN THAT FOLLOWS THE INITIAL SHOCK AND THEY HAVE TO USE A CANE UNTIL IT SUBSIDES. CALLER MENTIONED THAT THEY SPOKE TO THEIR DOCTOR ABOUT THIS ALREADY AND WAS RECOMMENDED NON-PHARMA TREATMENT AND PHYSICAL THERAPY, BUT THEY DIDN'T CHECK ANY ISSUES WITH THE IMPLANTED SYSTEM. CALLER NOTED THEY HAD A FALL IN AUGUST OR SO IN WHICH THEY LANDED FLAT ON THEIR CHEST AFTER TRIPPING, BUT THE SHOCKING SENSATION DIDN'T START RIGHT AFTER THE FALL. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084295 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male