BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 17440098 · Received August 2, 2023

    Report

    Report Number
    3004209178-2023-13574
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    June 9, 2023
    Report Date
    August 1, 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
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 97755, SERIAL# (B)(6). PRODUCT TYPE RECHARGER. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 97755, SERIAL/LOT #: (B)(6), UDI#: (B)(4). 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 REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS CALLER STATED THAT FOR ABOUT A WEEK THEY HAVE BEEN UNABLE TO DO ANYTHING WITH THEIR CONTROLLER. CALLER STATED IT DOESN'T SYNC UP TO RECHARGE AND EVERY TIME THEY TRY TO DO ANYTHING IT JUST SAYS DEVICE NOT FOUND. CALLER ADDED THAT FOR 2 -3 WEEKS PRIOR TO THIS THEY HAD BEEN HAVING TROUBLE GETTING IT TO SYNC UP FOR CHARGING, AND IT WOULD TAKE 2-3 ATTEMPTS BUT EVENTUALLY IT WOULD CONNECT. CALLER STATED IT JUST STOPPED WORKING LAST FRIDAY. AGENT HAD CALLER RESET THE CONTROLLER BATTERY. CALLER CONFIRMED NO VISIBLE DAMAGE TO THE EQUIPMENT. AGENT WALKED CALLER THROUGH ENTERING PASSIVE RECHARGE MODE WITH THE ANTENNA OVER THE RELAY BOX. CALLER SAW 91-91-91.CALLER RAISED THE PADDLE AWAY FROM THE RELAY BOX AND SAW 30-30-91. CALLER MOVED THE CORD AROUND AND SAW 0-0-100. THE ISSUE WAS NOT RESOLVED. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT. PT CALLED BACK STATING THAT THEY RECEIVED THE REPLACEMENT RECHARGER, HOWEVER THEY TRIED USING THE REPLACEMENT RECHAR GER AND THEY WERE EXPERIENCING THE SAME PROBLEMS. PT CONFIRMED THAT NO DEVICE FOUND WOULD APPEAR WHEN TRYING TO RECHARGE THE INS. PATIENT SERVICES (PSS) HAD THE PT INITIATE AN INS RECHARGING SESSION. PT SAW NO DEVICE FOUND APPEAR, SO PSS HAD THE PT TAP RECHARGER TO GO THROUGH PASSIVE RECHARGE MODE. PT SAW THE THREE NUMBERS APPEAR AS 100100 100 ON THE TRYING TO RECHARGE SCREEN; PT CONFIRMED THAT THE NUMBERS CHANGED WHEN THE RECHARGER PADDLE WAS MOVED AROUND. PT THEN SAW THE THREE NUMBERS ON THE TRYING TO RECHARGE SCREEN AS 80 98 100. PT SAW THE CONTROLLER LIGHT FLASHING GREEN. PT THEN SAW THE NORMAL RECHARGING SCREEN WITH THE CONTROLLER BATTERY AT 100% AND THE INS BATTERY AT 30% WITH RECHARGING EXCELLENT INDICATED. PSS REVIEWED BEST RECHARGING PRACTICES WITH THE PT. PT ASKED DURING THE CALL IF IT WAS NORMAL FOR THE RECHARGER PADDLE TO GET HOT WHEN TRYING TO RECHARGE THE INS; PT CONFIRMED THAT REPLACEMENT RECHARGER WAS NOT GETTING HOT; PT SAID THAT THE OLD RECHARGER WAS GETTING HOT AT TIMES; PSS REVIEWED REQUESTED INFORMATION WITH THE PT. PT SAID THAT THEY WERE IN A LOT OF PAIN AND THAT THEY HADN'T BEEN ABLE TO CHARGE THE INS FOR ALMOST A WEEK AND A HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796923 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male