BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3912428 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12491
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 8, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37791, SERIAL # UNKNOWN, PRODUCT TYPE RECHARGER; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE 2 ISSUES WITH THE RECHARGER. THE PATIENT¿S RECHARGER ANTENNA WAS HEATING UP TO THE POINT WHERE IT WAS NOT BURNING HIM, BUT IT GOT VERY, VERY WARM. THE MANUFACTURING REPRESENTATIVE TRACKED THE RECHARGER ANTENNA WIRE AND IT LOOKED LIKE THE RECHARGER ANTENNA WIRE MAY BE FRAYING. ALSO, SOME OF THE BUTTONS WERE ¿LAGGING¿ ON THE UNIT. THE MANUFACTURING REPRESENTATIVE THOUGHT THE BOARD UNDERNEATH THE RECHARGER BUTTONS WAS WORN OUT. THE MANUFACTURING REPRESENTATIVE HAD TO PUSH DOWN QUITE HARD TO GET THE BUTTONS TO ENGAGE. THIS ISSUE HAD BEEN GOING ON FOR ABOUT 3 MONTHS. IT WAS FURTHER REPORTED THAT THE MANUFACTURING REPRESENTATIVE HAD TO PULL THE IMPLANTABLE NEUROSTIMULATOR (INS) OUT OF OVERDISCHARGE. THE MANUFACTURING REPRESENTATIVE FIRST TRIED CHARGING THE IMPLANT NORMALLY AND HE WAS GETTING THE ¿REPOSITION ANTENNA¿ SCREEN. HE TRIED THE ANTENNA LOCATE (AL) BUT IT WAS NOT SUCCESSFUL. THE MANUFACTURING REPRESENTATIVE WENT THROUGH A 60 MINUTE PHYSICIAN MODE RECHARGE (PMR) AND HE TRIED TO INTERROGATE WITH THE CLINICIAN PROGRAMMER, BUT WAS NOT ABLE TO PROCEED. THEY TRIED 35-40 MINUTES OF A PMR AND TRIED TO INTERROGATE AGAIN, BUT THE CLINICIAN PROGRAMMER TOLD HIM THAT THE INS WAS DISCHARGED AND HE WAS NOT ABLE TO PROCEED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RECHARGER WOULD NOT CONNECT WHEN THE PATIENT PUTS IT UP BY THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT A COMMUNICATION PROBLEM WAS REPORTED. IT WAS FURTHER NOTED THE PATIENT WAS GETTING AN INFORMATION SCREEN. THE REPORTER STATED THEY RECHARGE EVERY TWO WEEKS. THE REPORTER FURTHER STATED THEY TRIED TO CHARGE YESTERDAY AND TODAY, BUT BEFORE THAT IT WAS TWO WEEKS AGO. IT WAS NOTED THE PATIENT HAD REPOSITIONED THE ANTENNA OVER THEIR SHIRT AND ON THEIR SKIN AND THAT HAS NOT CHANGED THE REPOSITION ANTENNA SCREEN THEY KEPT GETTING. IT WAS FURTHER NOTED THE PATIENT CHARGED TWO WEEKS AGO. THE REPORTER STATED THE INS SHUT OFF LAST NIGHT BECAUSE IT RAN ¿OUT OF JUICE.¿ THE REPORTER FURTHER STATED THEY HAD ALREADY SPOKEN TO A MANUFACTURING REPRESENTATIVE AND THEY THOUGHT IT WAS THE RECHARGER. IT WAS NOTED THE PATIENT FULLY CHARGES THE INS AND THEN LETS THE INS GO UNTIL IT¿S ALMOST DEAD BEFORE THEY RECHARGE. IT WAS FURTHER NOTED THE PATIENT HAD NOT SEEN ANY OTHER ERROR SCREENS AND THE ISSUE FIRST STARTED YESTERDAY. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT KEPT GETTING THE REPOSITION ANTENNA SCREEN. IT WAS NOTED THE PATIENT FULLY CHARGED UP TWO WEEKS AGO AND THEIR STIMULATION JUST STOPPED ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS IN OVERDISCHARGE. THE HEAD OF THE PATIENT¿S RECHARGER WAS NOT FUNCTIONING, SO HE WAS SENT A NEW RECHARGER. THE PATIENT DID RECEIVE A NEW RECHARGER AND EVERYTHING WAS WORKING WELL FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391781 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 00044 YR