BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3874234 · Received June 16, 2014

    Report

    Report Number
    3004209178-2014-11609
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    June 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 8591-38, LOT# D51774, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE PATIENT CONTACTED A MANUFACTURING REPRESENTATIVE. THE REPORTER STATED THEY WOULD CONTACT THE PATIENT TO SCHEDULE AN APPOINTMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURING REPRESENTATIVE WAS TRYING TO SCHEDULE TIME TO MEET WITH THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT THEY WERE WORKING WITH THEIR HCP OR A MANUFACTURING REPRESENTATIVE. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT REPROGRAMMING WAS PERFORMED ON (B)(6) 2014. THE PATIENT WAS SEEN AT THE PHYSICIAN'S OFFICE WHERE, AFTER REPROGRAMMING PERFORMED BY THE MANUFACTURER'S REPRESENTATIVE, GOT GOOD COVERAGE AND WAS DOING WELL. IT WAS REVIEWED WITH THE PATIENT HOW TO MANUALLY ADJUST UP OR DOWN AND TO STAY IN THE SAME POSITION FOR MORE THAN 3 MINUTES FOR THE INS TO "LEARN" THE NEW PREFERRED SETTING. IT WAS ALSO REPORTED THAT THE PATIENT HAD GREATER THAN 50% REDUCTION IN THEIR PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SAW A REPRESENTATIVE 2 WEEKS POST-OPERATIVELY WHEN THE DOCTOR TOOK THEIR STAPLES OUT AND THEN AGAIN THE THURSDAY PRIOR TO THE REPORT TO SET UP ADAPTIVE STIMULATION. AFTER THE ADAPTIVE STIMULATION SESSION THE PATIENT NOTICED THAT WHEN THEY WOULD LIE DOWN THE STIMULATION SENSATION WOULD BE TOO STRONG. THE REPRESENTATIVE WAS NOT AWARE OF THIS ISSUE AS THE PATIENT NOTICED IT WHEN THEY WERE GOING HOME FROM THE PROGRAMMING SESSION. THE PATIENT ALSO SUSPECTED THAT THEY MAY HAVE FELT A DIFFERENCE IN THE STIMULATION SENSATION SINCE THEY WERE PROGRAMMED ON A PHYSICIAN TABLE AND THEY LAYED DOWN AT HOME ON THEIR WATER BED. THE PATIENT EXPERIENCED THE TOO STRONG STIMULATION THE THURSDAY AND FRIDAY NIGHT PRIOR TO THE REPORT AND THEY USED THEIR PROGRAMMER TO TURN THEIR STIMULATION DOWN. THE PATIENT WAS PLANNING TO HAVE THEIR SETTINGS ADJUSTED IN THE FUTURE. THE PATIENT WAS SLOWLY COMING OFF PAIN MEDICATIONS TO SEE HOW EFFECTIVE THEIR STIMULATION THERAPY WAS FOR THEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352316 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