BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3905268 · Received July 1, 2014

    Report

    Report Number
    3004209178-2014-12329
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 26, 2014
    Report Date
    June 9, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LAST COUPLE WEEKS PRIOR TO REPORT ¿THINGS WERE NOT RIGHT¿ FOR THE PATIENT. IT WAS STATED THAT DURING THE LAST COUPLE WEEKS PRIOR TO REPORT THE PATIENT¿S ADAPTIVE STIMULATION (AS) SETTING WOULD CHANGE FROM UPRIGHT TO LAYING DOWN WHEN SHE LEANED BACK WHILE SITTING. THE PATIENT NOTED THAT SHE DID NOT REMEMBER THE AS BEING THAT SENSITIVE BEFORE. IT WAS REPORTED THAT OF THE PATIENT¿S TWO SETTINGS, ONE SHE COULD ONLY TOLERATE AROUND 3.7 VOLTS AND WAS FEELING MORE TINGLING IN BOTH OF HER LEGS AND THAT THE OTHER SHE DID NOT GET A RESPONSE UNTIL SHE TURNED IT UP TO 5 VOLTS. IT WAS STATED THIS HAD ONLY BEEN THE CASE FOR THE PATIENT DURING THE LAST WEEK OR SO PRIOR TO REPORT. IT WAS ALSO REPORTED THE PATIENT WOULD ADJUST HER AS AND STAY IN THE SAME POSITION FOR TEN MINUTES OR LONGER AND THAT HER STIMULATION WOULD CHANGE ON ITS OWN, NOTING IT WOULD TURN OFF OR GO HIGH. IT WAS STATED THE PATIENT HAD MADE CHANGED HER SETTINGS AND THAT THIS WAS OCCURRING MORE OFTEN AND RANDOMLY THE LAST COUPLE WEEKS PRIOR TO REPORT. IT WAS NOTED THE PATIENT HAD NOT EXPERIENCED ANY FALLS OR TRAUMAS PRIOR TO REPORT AND HAD STARTED SOME BASIC YOGA THAT WAS APPROVED BY HER HEALTHCARE PROVIDER (HCP). THE PATIENT WAS REDIRECTED TO HER HCP. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382760 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR