BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 5919133 · Received August 31, 2016

    Report

    Report Number
    3004209178-2016-18028
    Event Type
    Injury
    Date Received
    August 31, 2016
    Date of Event
    November 1, 2015
    Report Date
    December 21, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 977C165, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CONSUMER VIA THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT LOST STIMULATION COVERAGE FOR HIS BACK IN (B)(6) 2015. HE WAS REPROGRAMMED, BUT HE ONLY GOT STIMULATION TO THE LEGS. WHEN THE PATIENT WAS PROGRAMMED LAST (B)(6), THERE WERE NO IMPEDANCE ISSUES PER THE MANUFACTURER REPRESENTATIVE; AT LEAST NONE WERE LISTED. THE PATIENT WAS PROGRAMMED ON ELECTRODES 8, 9, 10, 13, 14, AND 15 AT 450 USEC AND 60 HZ. REPROGRAMMING WAS NOT REDONE UNTIL ABOUT A WEEK PRIOR TO (B)(6) 2016 BY THE PHYSICIAN'S ASSISTANT; THE PATIENT WAS PROGRAMMED ON ELECTRODE PAIRS 0/1 AND 5/6, 1000 USEC, 60 HZ, AND GROUP IMPEDANCE WAS 686 OHMS. SINCE REPROGRAMMING ONE WEEK PRIOR TO (B)(6) 2016, THE PATIENT EXPERIENCED CRAMPING IN HIS LEG, SIDE, AND BACK WHEN HE MOVED A CERTAIN WAY. WHEN THE MANUFACTURER REPRESENTATIVE REDUCED THE 1000 USEC TO 300 USEC, THE PATIENT STILL FELT CRAMPING. X-RAYS TAKEN THE WEEK PRIOR TO (B)(6) 2016 DID NOT SHOW ANY LEAD MOVEMENT OR CONNECTION ISSUES. IMPEDANCE MEASUREMENTS REVEALED ELECTRODES 0, 3, 5, 8, AND 11 WERE GREATER THAN 10000 OHMS; IN ADDITION, 1 = 1142 OHMS, 2 = 1343 OHMS, 4 = 1158 OHMS, 6 = 812 OHMS, 7 = 1041 OHMS, 9 = 1167 OHMS, 10 = 1041 OHMS, 12 = 1014 OHMS, 13 = 1378 OHMS, 14 = 1343 OHMS, AND 15 = 1194 OHMS. IT WAS REVIEWED THAT THERE APPEARED TO BE A LEAD CONNECTION ISSUE OR POTENTIALLY SOME SORT OF FLUID SHORT THAT MIGHT BE CAUSING THE PATIENT TO FEEL THE CRAMPING SENSATION, EVEN WHEN THE HIGH IMPEDANCE ELECTRODES WERE NOT USED IN THE PROGRAMS. THE MANUFACTURER REPRESENTATIVE PLANNED TO PROGRAM THE PATIENT FURTHER TO SEE ABOUT GETTING COVERAGE WITHOUT CRAMPING. IF PROGRAMMING DID NOT RESOLVE THE CRAMPING ISSUE, THE HEALTHCARE PROFESSIONAL WAS TO DETERMINE NEXT STEPS. THERE WERE NO REPORTED FALLS OR TRAUMA RELATED TO THIS EVENT. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE WAS MADE AWARE OF THE ISSUE ON (B)(6) 2016. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE ON 09-AUG-2016 REPORTED THAT THE PATIENT HAD 4 ELECTRODES OUT OF RANGE, AND THE PATIENT WAS BEING SENT TO THE IMPLANTING HEALTHCARE PROFESSIONAL TO DISCUSS REVISION. THE PATIENT'S INDICATIONS FOR USE INCLUDED FAILED BACK SURGERY SYNDROME AND SPINAL PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A REP REPORTED THAT HE WAS TO SEE THE PATIENT ON (B)(6) 2016 FOR HIS POST OPERATIVE-APPOINTMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A REP. IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCE VALUES SEEN ON MULTIPLE CONTACTS TOWARD THE TOP OF THE LEAD AND THE PATIENT WAS STILL NOT GETTING THE COVERAGE THAT HE NEEDED AND HAD IN THE PAST. A REVISION SURGERY TOOK PLACE ON (B)(6) 2016, AND HIGH IMPEDANCE WAS STILL PRESENT ON THE NEW LEAD. THE TOP OF THE LEAD WAS OFF TO THE "GUTTER" AS THERE WAS SOME SORT OF RESTRICTION PREVENTING THE HEALTHCARE PROFESSIONAL FROM GETTING THE LEAD INTO THE DESIRED LOCATION. THEY TESTED THE LEAD AND INS IN THE OPERATING ROOM AND EVERYTHING TESTED FINE, BUT WHEN THEY TESTED POST-OP THEY SAW THAT CONTACTS 0. 1, 2, 5, 6, 7, AND 8 SHOWED IMPEDANCE GREATER THAN 10,000 OHMS. THE REP DIDN'T TEST AT HIGHER VALUES, AND WAS TO FOLLOW-UP AND RETEST IMPEDANCE AT HIGHER VALUES AND COMPARE TO THE VALUES FROM (B)(6) 2016. IT WAS NOTED THAT THE PATIENT RECOVERED COMPLETELY. THE REP WAS ABLE TO PROGRAM AROUND THE HIGH IMPEDANCE CONTACTS AND GET THE PATIENT'S STIMULATION BACK TO THE BASELINE LEVEL FROM THE INITIAL IMPLANT. IT WAS NOTED THAT POSSIBLE EFFECTS OF THE LEAD NOT TOUCHING ANY TISSUE, AND SCAR TISSUE WERE DISCUSSED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE REP INDICATED THAT ALL IMPEDANCES WERE WITHIN NORMAL LIMITS AND THE PATIENT WAS RECEIVING EFFECTIVE PAIN RELIEF AT THE POST OPERATIVE APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570408 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention