BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3673483 · Received March 11, 2014

    Report

    Report Number
    3004209178-2014-04270
    Event Type
    Injury
    Date Received
    March 11, 2014
    Report Date
    February 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 377860, LOT# V011437, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER; PRODUCT ID 377860, LOT# V011437, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN IMPEDANCE READING OF >3600 OHMS. IT WAS NOTED THAT EVERY SINGLE ELECTRODE PAIR WAS SHOWING GREATER THAN 3600 OHMS, BUT PATIENT WAS STILL FEELING STIMULATION. IT WAS NOTED THE PATIENTS DEVICE CURRENTLY FELT "GOOD IN THE LEGS". IT WAS REPORTED THAT ONLY ONE IMPEDANCE TEST WAS PERFORMED AT .24V FOR THE DEVICE. IT WAS REPORTED THE SYSTEM HAD HIGH IMPEDANCES. IT WAS REPORTED THE PATIENT WAS PROBABLY GOING TO GET SYSTEM REPLACED WITH ANOTHER DEVICE SINCE HE HAD MS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145260 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention