BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2870701 · Received December 12, 2012

    Report

    Report Number
    3004209178-2012-11762
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 20, 2012
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3998 LOT# V005952, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708340 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708340 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WASN'T WORKING PROPERLY BUT FOR THE FIRST COUPLE OF YEARS IT WORKED REALLY WELL. OVER TIME HOWEVER, STIMULATION HAD STARTED "MOVING AROUND TO THE FRONT" AND BOTHERED HER STOMACH. IT WAS STATED THAT THE PATIENT WANTED STIMULATION IN HER LEFT LEG BUT IT WENT MORE TO HER RIGHT LEG. UNLESS THE PATIENT LAY FLAT, SHE DIDN'T GET GOOD RELIEF. THE PATIENT HAD ALSO HAD A LOT OF FALLS. IT WAS ALSO INDICATED THAT THE PATIENT HAD AN X-RAY DONE AND IT WASN'T CLEAR IF THE LEADS WERE INTACT OR ATTACHED PROPERLY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1