BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 16112382 · Received January 6, 2023

    Report

    Report Number
    3004209178-2023-00242
    Event Type
    Injury
    Date Received
    January 6, 2023
    Date of Event
    November 24, 2022
    Report Date
    January 6, 2023
    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
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97745 LOT# SERIAL# (B)(4) PRODUCT TYPE PROGRAMMER, PATIENT 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 REASON FOR CALL WAS PT STATED THEY HAD HAD STIM ON OR CHARGED FOR A WHILE BECAUSE THEIR STIMULATION WAS SPASMING WHEN PT HAD STIM ON AROUND THANKSGIVING, CONFIRMED END OF NOVEMBER. PT MENTIONED THEY FELL ON THEIR WALKER AND BROKE A RIB. PT SAID THE CONTROLLER HADN'T BEEN CHARGED FOR A WHILE AND THEY TRIED TO USE THE CONTROLLER AGAIN NOW BUT COULDN'T GET "IT" TO COME ON AND LATER SAID WHEN THEY TRIED TO USE CONTROLLER, CONTROLLER DIDN'T DO ANYTHING. PT SAID THEY HADN'T CHARGED BETWEEN THANKSGIVING AND TRYING TO USE CONTROLLER AGAIN. PT PLUGGED CONTROLLER IN TO AC POWER AND SAID GREEN LIGHT WAS ON AC POWER BUT NO GREEN LIGHT ON CONTROLLER AND SCREEN SHOWED BATTERY EMPTY, RECHARGE CONTROLLER. PT PLUGGED CONTROLLER IN TO AC POWER WITHOUT LI BATTERY AND CONFIRMED SCREEN CAME ON. PT DIDN'T SEE ANY DAMAGE TO BATTERY COMPARTMENT AND WHEN BATTERY WAS REINSERTED, PT CONFIRMED GREEN LIGHT WAS BLINKING. PT ALSO DESCRIBED THE CONTROLLER TIME BEING AN HOUR AHEAD. PSS REVIEWED TO LET CONTROLLER CHARGE, THEN TRY TO CHARGE IMPLANT AGAIN. PSS REVIEWED NO DEVICE FOUND TROUBLESHOOTING AND REVIEWED TO CALL BACK FOR ASSISTANCE CHARGING TOMORROW IF NEEDED. PSS ALSO REDIRECTED TO DOCTOR SHOULD THE STIM ISSUE CONTINUE AFTER PT CHARGED UP AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514011 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other