BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3027800 · Received March 29, 2013

    Report

    Report Number
    3004209178-2013-04401
    Event Type
    Injury
    Date Received
    March 29, 2013
    Report Date
    March 12, 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 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 377745, LOT # V020481, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 377745, LOT # V020481, IMPLANTED: (B)(4) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATED THE THERAPY WAS NOT EFFECTIVE ANYMORE AND NO LONGER HELPED WITH THE PAIN. IT WAS NOTED THAT THE PATIENT DECIDED TO REMOVE THE SYSTEM BECAUSE THE THERAPY WAS NOT WORKING FOR HIM. IT WAS INDICATED THAT THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130951 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention