BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4865966 · Received June 24, 2015

    Report

    Report Number
    3004209178-2015-12132
    Event Type
    Injury
    Date Received
    June 24, 2015
    Report Date
    June 3, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT # V123485, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SERIAL # (B)(4)) FOUND NO SIGNIFICANT ANOMALY. THE DEVICE HAD REDUCED CAPACITY DUE TO OVERDISCHARGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FOUND IT VERY INCONVENIENT TO HAVE TO RECHARGE EVERY 4 DAYS. THE DEVICE HAD BEEN DISCHARGED ONCE AND THE PATIENT WAS VERY CAREFUL TO KEEP IT CHARGED. THE PATIENT ALSO TURNED STIMULATION OFF SO IT DIDN¿T DEPLETE AS QUICKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408989 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 00066 YR Required Intervention