BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 9582694 · Received January 13, 2020

    Report

    Report Number
    3004209178-2020-00928
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    December 26, 2019
    Report Date
    February 6, 2020
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377760, LOT#: V010867, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37711, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE HCP EXPECTED THE LEAD TO BE SEEDED IN THE INS WHEN HE OPENED THE POCKET UPON REPLACEMENT SURGERY. THE LEAD WAS NOT IN THE INS AT ALL, IT HAD COME DISLODGED FROM THE INS. IT WAS UNKNOWN IF IT WAS NOT TIGHTENED PROPERLY BEFORE AND IT CAME OUT OF THE INS. THE CAUSE OF THE HIGH IMPEDANCES WAS NOT DETERMINED. NO ACTIONS WERE TAKEN TO RESOLVE THE HIGH IMPEDANCE. THE HCP PUT THE LEAD INTO THE NEW INS AND WILL BRING THE PATIENT BACK FOR A LEAD REVISION AT A LATER TIME IF NEEDED. THIS LEAD WAS NOT BEING USED FOR PATIENT MANAGEMENT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR COMPLEX REGIONAL PAIN SYNDROME TYPE I AND SPINAL PAIN VIA A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT WASN'T EXPERIENCING ANY SYMPTOMS. THE PATIENT WAS GETTING GOOD STIMULATION COVERAGE PRIOR TO END OF SERVICE (EOS) OF BATTERY WHICH OCCURRED SOMETIME IN (B)(6) 2019. THE REP REPORTED THAT UPON REPLACING THE INS ON (B)(6) 2019, IT WAS NOTED THAT ONE OF THE LEADS WASN'T IN THE INS, IT WAS JUST SITTING OUTSIDE THE GENERATOR IN THE POCKET. THE REP REPORTED THAT WHEN REPLACING TO A NEW INS AND CHECKING IMPEDANCES, THE LEAD WHICH WAS SEATED IN THE 8-15 PORT HAD IMPEDANCES ALL GREATER THAN 40,000 OHMS. THE REP REPORTED THAT NO INTERVENTIONS WERE TAKEN TODAY BY THE HCP. THE INS WAS REPLACED. THE REP REPORTED THAT THE HCP WOULD TAKE THE PATIENT BACK TO SURGERY TO REPLACE THE LEAD IF NEEDED AT A LATER TIME. THE REP NOTED THAT SINCE THE PREVIOUS INS WAS AT EOS, NO PREVIOUS IMPEDANCES OR PROGRAMMED SETTINGS WERE AVAILABLE FOR COMPARISON. THERE WERE NO FACTORS KNOWN THAT COULD HAVE CONTRIBUTED TO THE ISSUE. THE REP NOTED THAT THE ISSUES WERE FOUND THE DAY OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43191 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR