BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 5088550 · Received September 18, 2015

    Report

    Report Number
    3004209178-2015-18271
    Event Type
    Injury
    Date Received
    September 18, 2015
    Report Date
    August 26, 2015
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3550-29, LOT# N141210, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 355029, LOT# N091751, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4)

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE VIA THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE PATIENT'S BATTERY HAD REACHED END OF SERVICE (EOS) AND THE LEADS WERE REVISED. THE PATIENT WAS UNABLE TO CHARGE SO THE DEVICE WAS INTERROGATED. AFTER PERFORMING A PHYSICIAN MODE RECHARGE (PMR) THE END OF SERVICE (EOS) MESSAGE WAS DISPLAYED AND THE PATIENT WAS NOT GETTING COVERAGE IN THEIR LEFT FOOT. THE MANUFACTURER REPRESENTATIVE WAS ABLE TO CHECK IMPEDANCES, ALL WERE OKAY, HOWEVER, THEY WERE UNABLE TO PROGRAM THE STIMULATOR. IMAGING WAS TAKEN AND X-RAYS DID NOT SHOW ANY OBVIOUS ISSUES. THE PLAN WAS TO SEE IF BETTER COVERAGE COULD BE ACHIEVED AND IF SO THEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WOULD BE REPLACED AND IF NOT THE SYSTEM WOULD BE EXPLANTED. THE PATIENT WAS TAKEN TO THE OR AND THE RIGHT MOST LEAD WAS MOVED DOWN AND THE PATIENT WAS FEELING TINGLING IN THEIR LEFT FOOT WHICH BETTER COVERED THEIR FOOT PAIN THAT WHAT IT PREVIOUSLY HAD SO THEY PROCEEDED WITH THE BATTERY REPLACEMENT. THE INDICATION FOR USE WAS FOR PERIPHERAL NEUROPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619278 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 00058 YR Required Intervention