BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2848036 · Received November 28, 2012

    Report

    Report Number
    3004209178-2012-10839
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    October 28, 2012
    Report Date
    October 31, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 399945, LOT # V587365, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3986A, LOT # N247603, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT # V746983, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMME; PATIENT PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET (POR) OCCURRED. THE PATIENT EXPERIENCED LESS THAN 50% THERAPY RELIEF. IT WAS STATED THAT THE POR WAS SUCCESSFULLY CLEARED. THE REPORTER STATED THAT THE PATIENT WAS UNDERGOING 30 TREATMENTS OF RADIATION THERAPY FOR BREAST CANCER. THE PATIENT HAD AN APPOINTMENT WITH HER HEALTH CARE PROFESSIONAL (HCP) AT THE BEGINNING OF (B)(6) 2012 FOR A SYSTEM CHECK. THE REPORTER STATED THAT THERE WAS NO INJURY OR ADVERSE EVENT RELATED TO THIS EVENT. IT WAS LATER REPORTED THAT THE POR CONDITION OCCURRED AFTER "A FEW" RADIATION SESSIONS. IT WAS NOTED THAT THE TOTAL RADIATION DOSAGE PER RADIOLOGIST WAS 33.5 CENTIGRAY (CGY). SUBSEQUENT INFORMATION RECEIVED IN (B)(6) 2012 REPORTED THAT THE SYSTEM CHECK WITH THE HCP FOUND THE DEVICE TO BE WORKING AND INTACT. IT WAS ALSO STATED THAT THE IMPEDANCES WERE CHECKED. THE PATIENT OUTCOME WAS REPORTED AS STILL RECEIVING RADIATION THERAPY. THE PATIENT WOULD FOLLOW-UP WITH HCP ONCE THE RADIATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 00041 YR