BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4992727 · Received August 11, 2015

    Report

    Report Number
    3004209178-2015-15808
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    March 8, 2012
    Report Date
    July 24, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE DEVICE STOPPED WORKING FOLLOWING A FALL. THE PATIENT REPORTED THAT THE DEVICE WAS REPLACED (B)(6) 2012 DUE TO THE LEAD. SHE HAD FALLEN ON THE LEAD AND IT WAS NOT WORKING. THE PATIENT STATED THAT "WHEN THEY TOOK THE LEAD OUT IT WAS BENT." IT WAS ADDITIONALLY REPORTED THAT THE PATIENT RECOVERED COMPLETELY. NO RELEVANT PATIENT HISTORY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523258 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 00042 YR Required Intervention