BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2994262 · Received March 8, 2013

    Report

    Report Number
    3004209178-2013-03478
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Report Date
    February 15, 2013
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS SEEN IN THE CLINIC TO ACTIVATE THE SENSOR. THE PATIENT'S COVERAGE WAS GOOD AND THE PATIENT HAD GOOD PAIN RELIEF. THE PATIENT DID STILL HAVE EDEMA OVER THE STIMULATOR AND LEAD INCISION WHICH INCREASED WHEN THE PATIENT RECHARGED THE DEVICE. IT WAS NOTED THIS WAS NOT CAUSING THE PATIENT DISCOMFORT. ALL IMPEDANCES WERE WITHIN NORMAL LIMITS AND THE CLINIC NOTED THE PATIENT HAD NOT CALLED IN WITH ANY FURTHER CONCERNS.

    Description of Event or Problem · 1

    IT WAS NOTED THAT WHEN THE PATIENT CHANGED POSITIONS THEY FELT THE STIMULATION DIFFERENTLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A FLUID AT THE INCISION IN PATIENT'S MIDDLE BACK WHERE THE LEADS HAD BEEN PUT IN. THIS STARTED BETWEEN ONE AND ONE AND A HALF WEEKS AGO. THERE WAS A BUBBLE RANGING IN SIZE BETWEEN 1/2 OF A BASEBALL AND AN EGG WHICH WENT DOWN 1-1.5 HOURS AFTER THE PATIENT WOKE UP. ONE DAY BEFORE THE REPORT PRIOR TO CHARGING THERE WAS NO FLUID, WHEN THE PATIENT STARTED CHARGING SHE COULD FEEL THE FLUID STARTED TO FILL UP. NO FLUID AROUND THE INS, BUT IT WAS SORE. A SHOCKING OR JOLTING SENSATION WAS ALSO REPORTED. IT WAS STATED THAT A SMALL SHOCK HAPPENED EVERYDAY. IT WAS ALSO STATED THAT THE PATIENT HAD TO INCREASE THE STIMULATION EVERY DAY. THE PATIENT STARTED AT 4.1 V ON THE LEFT SIDE AND NOW WAS UP TO 5.2 V. THE PATIENT WAS NOT GETTING GOOD COVERAGE IN HER LOW BACK. IT WAS ALSO REPORTED SHE WAS NOT ABLE TO CHARGE WHEN SHE WAS SITTING UPRIGHT; SHE HAD TO LAY ON HER SIDE TO CHARGE. THE PATIENT HAD AN APPOINTMENT ON THE DAY OF THE REPORT AND IN TWO WEEKS AFTERWARDS FOR REPROGRAMMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE LAST APPOINTMENT WAS ON (B)(6) 2013 AND THE NEXT APPOINTMENT WAS SCHEDULED FOR (B)(6) 2013.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS FINE AND THAT THERE WAS NO MORE SWELLING. THE PATIENT WAS NOTED AS HAVING GOOD COVERAGE FOR THEIR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100354 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1