BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3882080 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-11779
    Event Type
    Malfunction
    Date Received
    June 18, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF D11: PRODUCT ID 97754 LOT# SERIAL# NKU102308N IMPLANTED: EXPLANTED: PRODUCT TYPE RECHARGER PRODUCT ID 39286-65 LOT# SERIAL# VA0AV77018 IMPLANTED: 2013-10-24 EXPLANTED: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE VOLTAGE VALUES WERE DECREASING ON THEIR OWN ON THE PATIENT PROGRAMMER. IT WAS NOTED THAT THIS OCCURRED RANDOMLY IN ALL POSITIONS AND HAD BEEN OCCURRING SINCE SOMETIME LAST MONTH. IT WAS NOTED THE MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT ON THE DAY OF THIS REPORT. THE REPORTER STATED THE VOLTAGE CHANGED WHILE THE PATIENT WAS MAINTAINING A POSITION AND NO CHANGES HAD BEEN MADE TO THE VOLTAGE. THE REPORTER FURTHER STATED THAT WHEN THE PATIENT WAS STANDING THE PROGRAMMER SHOWED 2.5 V AND THEN STIMULATION WOULD ¿SHOOT UP¿ AFTER TWO MINUTES ON ITS OWN TO 3.6 V. IT WAS NOTED THAT STIMULATION WOULD ALSO DECREASE THE SAME WAY. IT WAS FURTHER NOTED THAT THIS WOULD OCCUR WHEN THE PATIENT WAS IN LYING POSITIONS. THE REPORTER STATED THAT STANDARD TRANSITION VALUES WERE BEING USED. THE REPORTER FURTHER STATED THAT THE PATIENT PROGRAMMER SHOWED THE APPROPRIATE POSITION, BUT STIMULATION WENT FROM 2.5 TO 3.6 WHILE BEING UPRIGHT. IT WAS NOTED THE MANUFACTURING REPRESENTATIVE WAS NOT AWARE OF ANY CHANGES TO VOLTAGES DURING THESE EVENTS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT VOLTAGE FOR PROGRAM 1 ON GROUP A CHANGED FROM 2.5 TO 1.6 V WHILE THE PATIENT WAS UPRIGHT. IT WAS NOTED THE PATIENT DID NOT MAKE ANY CHANGES TO VOLTAGES DURING THAT TIME. IT WAS FURTHER NOTED THAT 1.6 V WAS NOT CURRENTLY ASSIGNED TO ANY POSITION. THE REPORTER STATED THEY DID NOT CHECK THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE CLINICIAN PROGRAMMER AND THEY WORKED WITH THE PATIENT PROGRAMMER. THE REPORTER FURTHER STATED THE CHANGES IN STIMULATION WERE USUALLY DECREASES AND THE PATIENT HAD TO MANUALLY INCREASE STIMULATION TO GET IT BACK TO THE DESIRED LEVEL. IT WAS NOTED THAT AFTER THE PATIENT MADE THE MANUAL INCREASE TO THE DESIRED LEVEL, STIMULATION WOULD STAY THERE FOR A WHILE OR CHANGE AGAIN LATER FOR THAT SAME POSITION. IT WAS FURTHER NOTED THE PATIENT DID USE MANUAL MODE AFTER IMPLANT FOR A SHORT PERIOD OF TIME WITH NO ISSUES. THE REPORTER STATED THE PATIENT HAD ONLY GROUP A WITH TWO PROGRAMS. IT WAS NOTED THAT UPRIGHT FOR PROGRAM 1 WAS 2.5V. IT WAS FURTHER NOTED THE PATIENT PROGRAMMER DISPLAYED THE CORRECT POSITIONS, BUT THE VOLTAGE WAS CHANGING UNEXPECTEDLY. THE REPORTER STATED THE ISSUE DID NOT SEEM TO BE RELATED TO THE PATIENT MAKING A POSITION CHANGE OR TO A LAG IN TRANSITION TIME. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT TO MEET WITH A MANUFACTURING REPRESENTATIVE ON THURSDAY. ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT ON THE DAY OF THIS REPORT. THE REPORTER STATED THE INS WAS RECOGNIZING THE POSITIONS CORRECTLY, BUT IT WAS ¿SELF-ADJUSTING¿ THE AMPLITUDES EVERY 30 SECONDS TO TWO MINUTES IN THE UPRIGHT AND LAYING DOWN POSITIONS. THE REPORTER FURTHER STATED THEY ADJUSTED THE LYING BACK AND UPRIGHT POSITIONS FROM ¿XXS TO XXL¿ AND THAT DID NOT HELP. IT WAS NOTED THE MANUFACTURING REPRESENTATIVE ADJUSTED THE MOBILITY RATE FROM BELOW MEDIUM TO LOW WHICH AUTOMATICALLY KNOCKED ALL OF THE AMPLITUDES TO ZERO. IT WAS FURTHER NOTED THE MOBILITY RATE WAS ADJUSTED TO ABOVE MEDIUM AND THE UPRIGHT POSITION WAS HOLDING THE PRESET AMPLITUDE. THE REPORTER STATED THE PATIENT WAS EXHAUSTED FROM REPEATED LYING DOWN AND STANDING ABACK UP SO REPROGRAMMING WAS STOPPED. THE REPORTER FURTHER STATED THEY WOULD CONTACT THE PATIENT AGAIN IN A COUPLE OF DAYS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT CONTACTED THE MANUFACTURING REPRESENTATIVE AND INDICATED THAT THE CHANGES MADE TO THE INS DID NOT STOP THE INS FROM RANDOMLY CHANGING THE AMPLITUDES. THE REPORTER STATED THE PATIENT WAS REQUESTING TO HAV THE INS REPLACED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358725 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