BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8915661 · Received August 21, 2019

    Report

    Report Number
    3004209178-2019-16070
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    June 1, 2019
    Report Date
    April 14, 2020
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10. CORRECTION TO DEVICE CODES IN SUPPLEMENTAL REPORT 001. 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: PRODUCT ID A710 LOT# UNKNOWN . PRODUCT TYPE SOFTWARE PRODUCT ID 3708220 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2011. PRODUCT TYPE EXTENSION PRODUCT ID 3708160 SERIAL# (B)(6) IMPLANTED: (B)(6) 2009. PRODUCT TYPE EXTENSION PRODUCT ID 3987A LOT# (B)(6) IMPLANTED: (B)(6) 2008. PRODUCT TYPE LEAD PRODUCT ID 3987A LOT# (B)(6) IMPLANTED: (B)(6) 2008. PRODUCT TYPE LEAD 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 A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP CLARIFIED THE COMMUNICATION ISSUE WITH THE TABLET; IT MUST HAVE BEEN THE TABLET. THE REP REPORTED THAT WHEN SHE TRIED HER COWORKER¿S TABLET, EVERYTHING WORKED FINE. THE REP REPORTED THAT SOFTWARE VERSION OF THE CLINICIAN THERAPY APP WAS 1.0.770. THE REP REPORTED THAT NO FURTHER ACTIONS/INTERVENTIONS WERE NEEDED TO RESOLVE THE ISSUE. THE REP REPORTED THAT CAUSE OF THE COMMUNICATION ISSUE WASN¿T DETERMINED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708220, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3987A, LOT#: N152134, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3987A, LOT#: N152134, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND THE BATTERY HAD INSIGNIFICANT ANOMALIES AND IT WAS FUNCTIONALLY OKAY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID 3987A, LOT # N152134, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. PRODUCT ID 3987A, LOT# N152134, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. THE REP REPORTED THAT THE PATIENT HAD AN ACCIDENTAL FALL WHILE LEARNING TO RIDE A MOTORCYCLE. THE REP REPORTED THAT SINCE THAT FALL, THE INS WASN¿T WORKING LIKE IT DID PRIOR TO THE ACCIDENT. THE PATIENT WANTED TO GET A REPROGRAMMING SESSION. THE REP REPORTED THAT ALL EXCEPT 2 ELECTRODES WERE ORANGE; THE TWO ELECTRODES 4 AND 6 WERE IN THE RED. THE REP ATT EMPTED REPROGRAMMING, BUT THE IMPEDANCE ON THE ELECTRODES SHOWED ALL BUT TWO WERE ORANGE AND 4 AND 6 WERE IN THE RED. THE REP REPORTED THAT THE ISSUE STILL PERSISTED. THE REP COULDN¿T USE ALL ELECTRODES TO REPROGRAM. THE PATIENT WAS ADVISED TO CONTACT HER DOCTOR F OR A CONSULT AND POSSIBLE REVISION SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS IN A MOTORCYCLE ACCIDENT DURING THE SUMMER OF 2019 WHICH PROMPTED A LOSS OF THERAPY BENEFIT. AT THE TIME OF THE REPORT, THE PATIENT WAS NOT GETTING ANY THERAPY BENEFIT. ALL IMPEDANCES WERE ELEVATED AND OUT OF RANGE. THE PHYSICIAN HAD ATTEMPTED REPROGRAMMING WITHOUT ANY THERAPY BENEFIT IMPROVEMENT. THE PATIENT HAD A REVISION ON THE DAY OF THE REPORT TO EXPLORE THE IMPEDANCE ISSUES. DURING SURGERY, ALL THE IMPEDANCES WERE RED. THE TABLET WOULD NOT CONNECT TO THE OLD BATTERY, SO A NEW ONE WAS USED. THE PATIENT¿S LEADS WERE FINE, SO JUST THE IMPLANTABLE NEUROSTIMULATOR WAS REPLACED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710283 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention