BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3790420 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08517
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 11, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 39286-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A SHOCKING OR JOLTING SENSATION. IT WAS REPORTED THAT THE PATIENT HAD SPORADIC JOLTING AND ¿SHOCKING ON HER LEG AND EVEN IN THE SHOULDER AND NECK¿. IT WAS STATED THAT THIS STARTED ABOUT TWO WEEKS AGO. IT WAS NOTED THAT IT HAPPENED WHEN ADAPTIVE STIM WAS ON AND WAS HAPPENING MORE NOW. IT WAS REPORTED THAT ADAPTIVE STIM WAS NOT CHANGING CORRECTLY. IT WAS STATED THAT THEY HAVE BEEN UNABLE TO GET IT TO WORK, AND IT WAS NOTED THAT THEY ORIENTED CORRECTLY. IT WAS REPORTED THAT WHEN THE PATIENT CHANGED FROM LYING TO UPRIGHT OR VICE VERSA IT DIDN¿T CHANGE VOLTAGES. IT WAS NOTED THAT THROUGH TROUBLESHOOTING IT WAS DETERMINED THAT THE UPRIGHT AMPLITUDE WAS NOT CORRECT. IT WAS STATED THAT THE MANUFACTURER¿S REPRESENTATIVE REPROGRAMMED THE UPRIGHT AMPLITUDE. IT WAS STATED THAT AFTER REPROGRAMMING, THE PATIENT WALKED AND TRIED ADAPTIVE STIM. IT WAS STATED THAT WHEN SHE BENT OVER SHE FELT THE STIMULATION CHANGE. IT WAS NOTED THAT THE POSITION DISPLAYED UPRIGHT, AND IT WAS NOTED THAT ADAPTIVE STIM SEEMED TO BE WORKING NOW. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS GETTING SHOCKING AND JOLTING ONLY WITH ADAPTIVE STIM ON. IT WAS STATED THAT IT WAS STILL OCCURRING AND THE PATIENT HAS DECIDED THE THERAPY WAS BETTER WITH ADAPTIVE STIM OFF, SO SHE HAS TURNED IT OFF FOR THE TIME BEING. IT WAS REPORTED THAT IMPEDANCES WERE ALL FINE AND THAT MULTIPLE REPROGRAMMING SESSIONS WERE PERFORMED. IT WAS STATED THAT NO MALFUNCTIONS WERE SEEN AND NO CAUSE OF THE SHOCKING/JOLTING ISSUE HAD BEEN DETERMINED. NO INTERVENTIONS HAD BEEN TAKEN OR PLANNED. IT WAS REPORTED THAT THE PATIENT WAS DOING BETTER WITH THE DEVICE WITH ADAPTIVE STIM OFF. IT WAS STATED THAT THE PATIENT HAS NOT EXPERIENCED ANY MORE SHOCKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268633 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR