BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 7806449 · Received August 22, 2018

    Report

    Report Number
    3004209178-2018-18898
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Report Date
    August 22, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3776-45, SERIAL (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37711, SERIAL (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3776-45, SERIAL (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 97715, SERIAL (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3776-60, SERIAL (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3776-60, SERIAL (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37711, LOT# SERIAL (B)(4) IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3776-45, (B)(4), UBD: 03-SEP-2012, (B)(4); PRODUCT ID: 3776-60, (B)(4), UBD: 27-FEB-2012, (B)(4); PRODUCT ID: 3776-60, (B)(4), UBD: 27-FEB-2012, (B)(4). REFER TO REGULATORY REPORT #3004209178-2018-18895 . THE PATIENT HAD TWO IMPLANTED SYSTEMS AND IT WAS NOT CLEAR WHICH ISSUES PERTAINED TO WHICH IMPLANTED SYSTEM. THE REFERENCED REPORT PERTAINS TO THE PATIENT¿S OTHER SYSTEM. THIS IS A CONTINUATION OF EVENTS PREVIOUSLY REPORTED IN REGULATORY REPORT #3004209178-2018-13168 AND REGULATORY REPORT #30042091 78-2018-18228. 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 NEURO STIMULATOR (INS) FOR SPINAL PAIN. THE REP REPORTED THAT THE CASE WENT WELL FOR THE PATIENT. THE REP REPORTED THAT THE PATIENT HAD TWO SYSTEMS. THE REP REPORTED THAT AN IMPEDANCE TEST WAS DONE WITH THE CERVICAL SYSTEM AND ALL ELECTRODES WERE WITHIN RANGE. THE REP REPORTED THAT AN IMPEDANCE TEST WAS DONE WITH THE THORACIC SYSTEM PRIOR TO REPLACEMENT AND IT INDICATED THAT ELECTRODES 11 AND 12 WERE OUT OF RANGE AND THIS DIDN¿T CHANGE AFTER THE NEUROSTIMULATOR (INS) WAS REPLACED. THE REP REPROGRAMMED THE PATIENT POST-OPERATIVELY AND IMPROVED COVERAGE WITH BOTH SYSTEMS, THORACIC AND CERVICAL. THE PATIENT WAS VERY HAPPY WITH THE RESULTS. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THEY MET WITH THE PATIENT FOR HIS POST-OPERATIVE APPOINTMENT. THE PATIENT WAS DOING PRETTY WELL BUT WANTED SOME REPROGRAMMING DONE. THE REP REPORTED THAT THEY REPROGRAMMED FOR IMPROVED COVERAGE ON BOTH SYSTEMS. THE REP REPORTED THAT THE PATIENT WAS CURRENTLY USING GROUP B FOR HIS THORACIC SYSTEM AT 0-4+, PULSE WIDTH 300, 50 RATE. THE REP IMPROVED COVERAGE OF THE LOWER BACK WITH LESS STIMULATION IN THE LEGS. THE REP REPORTED THAT AN IMPEDANCE TEST INDICATED THAT ELECTRODES 11, 13, 14, 5 AND 6 WERE OUT OF RANGE. THE REP REPORTED THAT THE PATIENT WAS USING GROUP B FOR HIS CERVI CAL SYSTEM AT 1-3+4+, PULSE WIDTH 200, RATE 90. THE REP REPORTED THAT AN IMPEDANCE TEST INDICATED THAT ELECTRODE 0 WAS OUT OF RANGE. THE REP PROVIDED COVERAGE OF THE PATIENT¿S LEFT SHOULDER AND NECK. THERE WAS SOME COMPONENT OF ARM STIMULATION THAT WAS UNAVOIDABLE. THE REP REPORTED THAT THE SENSOR WAS ACTIVATED AND ADJUSTED FOR BOTH SYSTEMS. THE REP ENABLED RATE FOR THE PATIENT BECAUSE HE WOULD LIKE TO TRY HIGH DENSITY. THE PATIENT WAS VERY HAPPY WITH THE RESULTS AND WOULD CONTACT THE REP IF HE HAD ADDITIONAL QUESTIONS OR NEEDED SUPPORT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646548 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1