BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3670515 · Received March 10, 2014

    Report

    Report Number
    3004209178-2014-04136
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Report Date
    February 17, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 37082-40, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 3998, LOT# V022880, IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT FELT LIKE STIMULATION WAS ¿CUTTING OFF BY ITSELF EVERY ONCE IN A WHILE¿. IT WAS STATED THAT THE ISSUES HAVE BEEN GOING ON FOR ¿1 MONTH OR 2¿. IT WAS REPORTED THAT THE PATIENT NOTICED THE IMPLANT WAS CUTTING OFF BECAUSE HER LEGS WOULD START HURTING AGAIN. IT WAS STATED THAT WHEN SHE CHECKED THE IMPLANT STATUS, IT SHOWED ¿OFF¿, AND WOULD USE THE PROGRAMMER TO TURN THE IMPLANT BACK ON. IT WAS STATED THAT THE IMPLANT HAS NOT DISCHARGED BECAUSE OF THE OFF EVENTS AND ¿DIDN¿T LET IT GET DOWN¿. IT WAS REPORTED THAT IMPEDANCE WAS TESTED AND ELECTRODE IMPEDANCES WERE ALL NORMAL. IT WAS STATED THAT IMPEDANCES WERE ALL BETWEEN 800 TO 900 OHMS, WITH A HIGHEST READING OF 986 OHMS. IT WAS NOTED THAT THE PATIENT WAS AT 300¿S, 45HZ, USING 4 POSITIVES AND 1 NEGATIVE, AT 7.5V ON PROGRAM B2. IT WAS STATED THAT THE PATIENT HAD A PROGRAM B1 BUT NOTHING WAS ACTIVE ON IT. IT WAS STATED THAT THERAPY I MPEDANCE WAS 418 OHMS. IT WAS NOTED THAT DURING TROUBLESHOOTING WITH THE IMPLANT ON, THE PATIENT REPORTED NOT FEELING STIMULATION SUDDENLY. NO IMPEDANCE ANOMALIES WERE FOUND AT THAT TIME. IT WAS STATED THAT THE MANUFACTURER¿S REPRESENTATIVE DELETED THE NONACTIVE B1 PROGRAM AND MADE THE B2 PROGRAM B1. IT WAS REPORTED THAT THE PATIENT STARTED FEELING STIMULATION WHEN THIS WAS DONE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE HAD NOT HEARD BACK FROM PATIENT AND ASSUMED SHE WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142917 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 00051 YR