BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4771712 · Received May 14, 2015

    Report

    Report Number
    3004209178-2015-09113
    Event Type
    Injury
    Date Received
    May 14, 2015
    Date of Event
    September 1, 2014
    Report Date
    April 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37092, LOT# 253500001, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATOR WAS WORKING WELL BUT TOWARDS THE END (B)(6) THE PATIENT EXPERIENCED NORMAL STIMULATION AND THEN STIMULATION OFF FOR 1-2 SECONDS AND THEN BACK TO NORMAL STIMULATION COVERAGE. THE DEVICE WAS EXPLANTED FOR THIS REASON. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316520 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 00062 YR Required Intervention