BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3940974 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-13154
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 29, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION. IT WAS NOTED THAT THE PATIENT CHARGED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AND TURNED THE LIGHTNING BOLT ON, BUT THE THERAPY DID NOT TURN ON. IT WAS FURTHER REPORTED THAT THE EVENT OCCURRED FOLLOWING A FALL. THE PATIENT REPORTEDLY FELL 2 TIMES ON ¿THE OTHER DAY¿ PRIOR TO THE REPORT AND FELT LIKE SOMETHING CAME LOOSE. IT WAS LATER REPORTED STIMULATION WAS TURNING OFF AND THERE WAS NO STIMULATION SENSATION. IT WAS NOTED THAT THE PATIENT WAS HAVING PROBLEMS STARTING THE STIMULATOR. IT WAS FURTHER REPORTED THAT THE BATTERY WENT DOWN JUST THE OTHER DAY MEANING IT GOT REALLY LOW. THE PATIENT REPORTEDLY LAST CHARGED TO 3/4 FULL ON THE DAY PRIOR TO THE DATE OF THE REPORT. IT WAS VERIFIED THE LIGHTNING BOLT WAS ON BUT THE PATIENT WAS NOT ABLE TO FEEL STIMULATION. IT WAS NOTED THAT THE LIGHTNING BOLT IS IN THE LEFT HAND CORNER SHOWING PROGRAM CHECK 8 AT 1.10 AMPLITUDE BUT THE PATIENT DID NOT FEEL STIMULATION. IT WAS ALSO NOTED THAT THE PATIENT INCREASED STIMULATION BUT DID NOT FEEL IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419750 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 00053 YR