BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3912453 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12492
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 11, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 355531, LOT# N287036, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: SCREENING DEVICE; PRODUCT ID 37092, LOT# 292330001, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE PATIENT PROGRAMMER. THE REPORTER STATED THAT STIMULATION HAD BEEN TURNING ITSELF DOWN STARTING THREE WEEKS TO ONE MONTH PRIOR TO THIS REPORT. THE REPORTER STATED THAT STIMULATION WOULD BE SET AT 2.90 AND THE PATIENT WOULD BE ABLE TO FEEL STIMULATION. IT WAS NOTED THAT THE PATIENT WAS LATER UNABLE TO FEEL STIMULATION AS MUCH AND STIMULATION WOULD BE AT 2.85 WHEN THE REPORTER CHECKED. IT WAS NOTED THAT THE PATIENT HAD MET WITH A MANUFACTURING REPRESENTATIVE TWO DAYS PRIOR TO THIS REPORT AND A REPLACEMENT PATIENT PROGRAMMER WAS RECOMMENDED. IT WAS NOTED THAT THE PATIENT HAD NOT USED AN ANTENNA IN THE PAST. IT WAS LATER REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THE DEVICE OR THERAPY BUT WAS WORKING WITH A HEALTH CARE PROVIDER OR MANUFACTURING REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391086 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 00057 YR