BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4182341 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19940
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE ¿CALL YOUR DOCTOR¿ ICON AS WELL AS A POWER ON RESET (POR) WAS DISPLAYED ON BOTH THE RECHARGER AND THE PROGRAMMER. THE MESSAGE KEPT POPPING UP. THE PATIENT STATED THAT THE MESSAGE WAS GONE TODAY, BUT IT STILL WOULDN¿T TURN ON THE STIMULATOR. THE PATIENT STATED SHE USUALLY DIDN¿T LET HER BATTERY GO LOW BUT IT HAD GONE DOWN ALL THE WAY BEFORE. THE PATIENT HAD A CT SCAN DONE 3 WEEKS AGO. THE PATIENT WAS REDIRECTED TO HER PHYSICIAN AS SHE WOULD NEED A PHYSICIAN CLEAR THE WARNING POR. ADDITIONAL INFORMATION REGARDING THE OUTCOME WAS REQUESTED. IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE HAD BEEN OVERDISCHARGED (OD) AS THE PATIENT HAD NOT CHARGED HER DEVICE. A COMPANY REPRESENTATIVE HAD CLEARED THE POR. THE DEVICE WAS RECHARGED AND THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THEIR PHYSICIAN AND/OR COMPANY REPRESENTATIVE AND THEIR CONCERNS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661414 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 00052 YR