BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3105067 · Received May 10, 2013

    Report

    Report Number
    3004209178-2013-07504
    Event Type
    Injury
    Date Received
    May 10, 2013
    Report Date
    April 23, 2013
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3776-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V083355, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37791, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3776-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V083355, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S LEGS WERE BURNING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INCREASED PAIN IN HIS LEGS DUE TO THE IMPLANTABLE NEUROSTIMULATOR (INS) NEEDING TO BE CHARGED. THE PATIENT WAS SCHEDULED FOR AN MRI. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT "JUST HAD ONE LEAD BREAK AND IT WAS REPLACED". IT WAS STATED THAT THE PATIENT DID NOT HAVE CONCERNS REGARDING THEIR DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206636 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 Required Intervention