BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 11259621 · Received February 1, 2021

    Report

    Report Number
    3004209178-2021-01740
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    January 2, 2021
    Report Date
    February 23, 2021
    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
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: 97755, SERIAL#: (B)(6), PRODUCT TYPE: RECHARGER. 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 FROM THE PATIENT REPORTED THAT NOTHING ORDINARY WAS DONE THAT LED TO THE RECHARGING DIFFICULTY. THE PATIENT REPORTED THAT THE DONUT ANTENNA WAS REPLACED AND THAT RESOLVED THE ISSUE ABOUT THE LENGTHY CHARGING TIME AND THE GLITCHES WITH THE CONTROLLER. THE PATIENT REPORTED A WEIGHT OF 180.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97755, SERIAL#: (B)(6), PRODUCT TYPE: RECHARGER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT REPORTED HAVING DIFFICULTY RECHARGING THE INS. PATIENT STATED THAT HE IS GETTING AN EXCELLENT RECHARGING CONNECTION, BUT ITS TAKING 2H TO CHARGE THE INS FROM 50-100%, FOR THE LAST 1-2 WEEKS THE INS WILL NOT CHARGE PAST 80% (NO MATTER HOW LONG HE CHARGES THE INS FOR), AND ABOUT 3 WEEKS AGO, THE SKIN AROUND THE IMPLANT SITE GOT "REALLY HOT, UNCOMFORTABLY HOT". PATIENT NOTED HIS SKIN GETTING HOT ONLY OCCURRED ONE TIME. PATIENT STATED THAT HE HAS ALREADY TRIED TROUBLESHOOTING IN-PERSON AT THE HCP'S OFFICE WITH THE REP AND HCP. PATIENT CONFIRMED THERE IS NO DAMAGE ON THE RTM CORD, BUT THE RELAY BOX WAS GETTING WARM. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE DAMAGED DEVICE (B)(6) 2021 MPXR 801520: ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT VIA A MANUFACTURER'S REPRESENTATIVE (REP). PATIENT IS ABLE TO GET EXCELLENT STATUS WHEN RECHARGING BUT IT¿S TAKING ABOUT 2X LONGER THAN IT SHOULD. HE¿S ALSO NOT ABLE TO GET HIS BATTERY TO CHARGE MORE THAN 80%. HE SAID HE BATTERY POCKET GETS HOT SOMETIMES TOO. PATIENT CONFIRMED HE IS ABLE TO EASILY GET EXCELLENT STATUS AND BATTERY DOES NOT APPEAR TO BE IMPLANTED TOO DEEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156977 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR "SEE H10...."