BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 8130284 · Received December 4, 2018

    Report

    Report Number
    3004209178-2018-26834
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    September 1, 2018
    Report Date
    January 2, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994610430
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) ON DECEMBER 4TH, 2018. THE REP REPORTED THAT NOTHING WAS DONE TO TRY TO RESOLVE THE HIGH IMPEDANCES BECAUSE IT WAS NOT AN ISSUE DUE TO THAT ELECTRODE NOT BEING NEEDED FOR PROGRAMMING. THE REP STATED THAT THE CAUSE OF THE BURNING SENSATION AT THE BATTERY SITE WHEN RECHARGING WAS NOT DETERMINED. THE PATIENT HAD NOT REPORTED BACK, BUT THE REP THOUGHT THAT IT WAS DUE TO THE PRESSURE OVER THE POCKET. THE PATIENT WAS GOING TO TRY PLACING THE RECHARGER OVER THE BATTERY FOR AN HOUR WITHOUT ACTIVELY RECHARGING TO SEE IF THE BURNING SENSATION STILL OCCURRED. THE REP WAS UNSURE IF THIS ISSUE HAD RESOLVED. THE PATIENT¿S WEIGHT WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER (CON) AND MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NE UROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN AND DEGENERATIVE DISC DISEASE. THE PATIENT REPORTED THAT THEY HAD A BURNING SENSATION AT BATTERY SITE WHEN RECHARGING, AND THAT THE ISSUE STARTED 2 MONTHS AGO. THE PATIENT REPORTED A FALL THAT WAS 11 MONTHS AGO. THE PATIENT STATED THAT THE ISSUE WAS ONLY OCCURRING WHILE RECHARGING. THE CALLER REPORTED THAT PALPATION OF THE AREA DIDN'T ELICIT A BURNING SENSATION. THERE WAS NO REPORT OF HEAT IN THE AREA, TO THE TOUCH. TECHNICAL SERVICES SUGGESTED PUTTING THE RECHARGER OVER THE IMPLANT SITE, BUT TO NOT START A RECHARGE SESSION AND TO SEE IF THAT STILL CAUSES THE BURNING SENSATION. AN IMPEDANCE CHECK SHOWED: 0 1001 OHMS 1 1740 2 1333 3 1301 4 1108 5 945 6 10K 24580 OHMS(3 VOLTS) 7 1063 8 1001 9 1141 10 1095 11 962 12 1001 13 1014 14 982 15 1006 OHMS THE REP REPORTED THAT THEY NOTICED ELECTRODE 6 BEING HIGH TODAY, LAST CHECKED A YEAR AGO AND THERE WAS NO ISSUE AT THE TIME. THE PATIENT HAD 2 PROGRAMS #1 11+ 13- PROG#2 12+ 15+ 13- 14-. TECHNICAL SERVICES TOLD THE CALLER THAT THE SYSTEM CHECKSHOWED NO IMPLANT ISSUE, THUS THE BURNING SENSATION MIGHT BE MORE MEDICAL IN NATURE. THE REP DID REPORT HAVING DISCONNECTION WITH THE INS WHILE CHECKING IMPEDANCE, BUT HE WAS ABLE TO RECONNECT, AND IT WORKED FINE. THERE WERE NOT ANY SIGNS OF SKIN IRRITATION. NO FURTHER COMPLICATIONS WERE ANTICIPATED/REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970457 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR