BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8491221 · Received April 8, 2019

    Report

    Report Number
    3004209178-2019-06870
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Date of Event
    March 1, 2019
    Report Date
    April 8, 2019
    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL CORD STIMULATION - NONMALIGNANT PAIN. IT WAS REPORTED IN THE PAST 10 DAYS, PATIENT WOULD NOTICE THAT RECHARGING WAS GETTING LONGER FROM 50 MINUTES TO 1.3-1.6 HRS. NO FALLS RELATED. NO POSITIONAL MOVEMENT RELATED. NO EMI RELATED. THE MANUFACTURER'S REPRESENTATIVE (REP) REPORTED THE FOLLOWING DATA FROM THE RECHARGER STATS: 1.0 HR, DATE NOT PROVIDED: 1.2 HR, (B)(6) 2019: 50 MIN (B)(6) 2019: 1.5 HR, (B)(6) 2019 20-100% 1.6HRS, (B)(6) 2019: 30-100% 1.3 HRS, (B)(6) 2019: 30-100% 1.2HRS, (B)(6) : 10- 100% TOOK 1.6 HR, (B)(6): 90-100% 50 MINS EXCELLENT COUPLING ON RECHARGING DATES. THE IMPEDANCES WERE REPORTED TO BE NORMAL: 800-1000 OHMS. PATIENT TURNS STIM OFF AND LETS SCREEN GO DARK WHILE CHARGING. NO PROGRAMMING CHANGES HAD BEEN MADE PRIOR TO THIS APT TODAY. PROGRAMMING ADJUSTMENTS DID OCCUR TODAY BUT NOT RELATED TO THE CHARGING TIME CONCERN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286988 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR