BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2943451 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-01289
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 15, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION. ADDITIONALLY, IMPEDANCES WERE NOT WITHIN NORMAL LIMITS ON BOTH LEADS. IT WAS ALSO NOTED THAT THERE WAS A BROKEN LEAD. IT WAS HOWEVER, UNCLEAR IF ONE OR BOTH LEADS BROKE. THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THE EVENT BUT SURGICAL INTERVENTION OCCURRED TO REPLACE BOTH LEADS. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ALSO REPLACED EVEN THOUGH THERE WAS NOTHING WRONG WITH IT. THE REPORTER INDICATED THAT THE PATIENT DESIRED TO HAVE A SENSOR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47566 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