BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 8722226 · Received June 21, 2019

    Report

    Report Number
    3004209178-2015-03265
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    November 1, 2013
    Report Date
    June 21, 2019
    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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37752, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708220, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37743, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3888-45, LOT#: V223086, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT#: V588268, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. THIS MEDICAL DEVICE REPORT IS BEING RESUBMITTED TO THE EMDR SYSTEM DUE TO A CONNECTION ERROR WITHIN THE EMDR SYSTEM. THE EVENT WAS PREVIOUSLY REPORTED TO THE EMDR PORTAL AND AN ACKNOWLEDGEMENT 3 RECEIVED, BUT THE CONNECTION ERROR PREVENTED THE EMDR SYSTEM FROM DOCUMENTING THE REPORT. THE REPORT NUMBER IN THIS REPORT IS THE SAME NUMBER AS THE IMPACTED REPORT THAT HAS THE CONNECTION ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REPLACEMENT BECAUSE HER FIRST HEALTHCARE PROVIDER (HCP) PUT THE IMPLANT UP IN THE BACK BEHIND THE RIBCAGE AND A LEAD CAME DISCONNECTED. THE HCP DIDN¿T UNDERSTAND THE LEAD/THERAPY WAS NOT SERVING THE PATIENT. SHE LEFT THE HCP¿S OFFICE CRYING IN PAIN AND THE HCP SAID THERE WAS NOTHING HE COULD DO FOR THE PATIENT. SHE FOUND A NEW GROUP OF HCP¿S WHO FOUND THE LEAD WAS DISCONNECTED ON ONE SIDE AND A REVISION WAS DONE WHICH WAS A BIG ORDEAL. THE EVENT STARTED IN (B)(6) OF 2013. THE PATIENT NOTED THAT NOW THEIR DEVICE WAS FABULOUS AND THERAPY WAS WORKING BEAUTIFULLY; SHE WAS GETTING 65% RELIEF FROM THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515413 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 47 YR Required Intervention