BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3913477 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12521
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    April 30, 2014
    Report Date
    February 22, 2019
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED STIMULATION/THERAPY ISSUES. THE PATIENT EXPERIENCED A LOSS OF STIMULATION/THERAPEUTIC EFFECT. IT WAS NOTED STIMULATION WAS IN THE CORRECT AREA AND WAS THERAPEUTIC SINCE IMPLANT. HOWEVER, IT WAS NOTED THAT A MONTH AGO STIMULATION ¿TOTALLY CHANGED.¿ THE COVERAGE WAS IN THE SAME/CORRECT AREA HOWEVER, NOW WHEN STIMULATION WAS TURNED ON IT INCREASED PAIN IN THE PROBLEM AREA. THE PATIENT NOTED THAT THE ¿INTENSITIES¿ (AMPLITUDE) WHEN THERAPY WAS THERAPEUTIC WAS AROUND 2.0 TO 2.5. IT WAS REPORTED THAT NOW 0.3 TO 0.8 CAUSED SO MUCH PAIN IT WAS UNBEARABLE. IT WAS NOTED THAT AS STIMULATION WAS TURNED ON, THE PATIENT¿S ORIGINAL PAIN INCREASED ¿EXPONENTIALLY¿ AS THE INTENSITIES WERE INCREASED. IT WAS NOTED PATIENT¿S SYMPTOMS OF PAIN AND LESS THAN 50% THERAPY RELIEF WERE LOCATED AT THE DEVICE POCKET AND LEAD LOCATION. THE PATIENT DENIED ANY FALLS OR OTHER ADVERSE EVENTS. THE PHYSICIAN REPORTEDLY ORDERED X-RAYS TO CONFIRM LEAD PLACEMENT. NO DIAGNOSTIC TESTING/TROUBLESHOOTING HAD BEEN PERFORMED BUT WOULD BE IN THE FUTURE. THE CAUSE OF THE ISSUE WAS UNKNOWN. THE PHYSICIAN REQUESTED VERIFICATION THAT THE PATIENT¿S UNIT WAS NOT INVOLVED IN A RECALL. THE PATIENT REPORTEDLY FOUND SOMETHING ON THE INTERNET AND WAS SUSPICIOUS IF HIS UNIT WAS INVOLVED. IT WAS CONFIRMED THAT THERE WAS NO RECALL INVOLVING THE PATIENT¿S DEVICES (LEAD OR STIMULATOR) AND THE PATIENT WAS NOTIFIED OF THESE FINDINGS. IT WAS UNKNOWN IF ACTION WAS REQUIRED AS A RESULT OF THE EVENT. IMPEDANCE TESTING AND REPROGRAMMING WAS PERFORMED. IMPEDANCES SHOWED ALL CONTACTS WERE BETWEEN 712 AND 832 OHMS. REPROGRAMMING IN ALL LOCATIONS OF THE 5-6-5 ELICITED THE SAME RESPONSE AT VERY LOW 0.3-0.8 INTENSITIES. THE PATIENT¿S STATUS WAS NOTED TO BE ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS INSTRUCTED TO GET X-RAYS AS SOON AS POSSIBLE. THERE HAD BEEN NO COMMUNICATION BETWEEN THE PATIENT AND THE REP SINCE THE OFFICE VISIT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT FOLLOWED UP WITH THE PHYSICIAN ON (B)(6) 2014 AT 0900. X-RAYS WERE TAKEN AND IT APPEARED THE LEADS HAD MOVED 1-2 CONTACTS. THE PATIENT WAS REFERRED TO ANOTHER PHYSICIAN. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT FOLLOWED UP WITH THE REFERRED PHYSICIAN ON (B)(6) 2014 AT 1240. THE PATIENT REPORTEDLY EXPERIENCED DISCOMFORT. THE PHYSICIAN INSTRUCTED THE PATIENT TO ¿SHUT THE UNIT COMPLETELY OFF FOR 2-4 WEEKS¿ BECAUSE THE NERVE ENDINGS WERE OVERSTIMULATED, AND THERE WAS AN INCREASE IN SCAR TISSUE AROUND THE NERVE ENDINGS, BOTH OF WHICH WERE CONTRIBUTING TO THE PATIENT¿S PAIN. IT WAS NOTED THAT IF PAIN CONTINUED AFTER THE 2-4 WEEK BREAK THE PATIENT SHOULD TALK TO THE PREVIOUS PHYSICIAN ABOUT LONG TERM DISABILITY, DUE TO THE FACT THE PATIENT COULD NOT CONTINUE HIS CURRENT PROFESSION AS A MECHANIC. IT WAS NOTED THE STIMULATOR WAS NOT GOING TO HELP, AND REPORTEDLY SHOULD BE EXPLANTED FROM THE PATIENT¿S BODY. THE REP WAITED IN THE WAITING AREA AND THE INFORMATION WAS REPORTEDLY RELAYED TO THE REP THROUGH THE PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT REPORTING THAT THE PATIENT STATED TWO WEEKS AGO THEY TRIED TO TURN THEIR STIMULATION ON AND THEY WEREN¿T ABLE TO TURN STIMULATION ON AND WERE NOT ABLE TO CHARGE THE INS. THEY REPORTED THAT THE PATIENT HAD TURNED THEIR DEVICE OFF AND STOPPED USING THEIR IMPLANT 13 MONTHS AFTER THEY WERE IMPLANTED AS THE DEVICE STOPPED HELPING WITH THEIR PAIN. THEY INDICATED THAT THEIR DEVICE WAS IMPLANTED FOR PAIN IN THEIR LEGS. THEY HAD MET WITH A REP SEVERAL TIMES IN THE HOSPITAL LOBBY AND TRIED EVERY PROGRAM POSSIBLE AND THE DEVICE DID NOTHING FOR THE PATIENT SO THE PATIENT TURNED THE DEVICE OFF. THE PATIENT STATED THAT CURRENTLY THEY HAD EXTREMELY BAD LEG PAIN. THE PATIENT STATED THAT THEY WERE IN SUCH BAD PAIN NOW THAT WHEN THEY GOT UP IN THE MORNING THEY HAD TO SIT ON THE BED FOR 15 TO 20 MINUTES UNTIL THEY COULD STAND UP. THE PATIENT STATED THAT ¿WHEN THEY WALKED THEY COULD GET PINCHED FROM THEIR HIP TO THEIR ANKLE AND WOULD GET A BALL IN THEIR FOOT¿. THEY PATIENT STATED THAT THEY HAD TO WATCH WHICH WAY THEY TURNED BECAUSE THE PAIN WOULD SHOOT DOWN THEIR LEG. THE PATIENT STATED THAT NO ONE TOLD THEM THAT THEY NEEDED TO KEEP CHARGING THE INS EVEN WHILE IT WAS OFF. THE PATIENT HAD LEG PAIN THAT WAS GETTING WORSE AND ON (B)(6) 2017 IT WAS REPORTED THAT THE PATIENT HAD A HEART ATTACK AND BEEN PLACED ON DISABILITY. THE PATIENT STATED THAT THE SURGERY TO HAVE THEIR DEVICE IMPLANTED WAS NOT AN EASY SURGERY AND WHEN THEY SAT BACK THEY FELT THE BATTERY ¿ROLLING AROUND IN THEIR BACK¿. THE PATIENT WAS REDIRECTED TO FOLLOW-UP WITH THEIR HEALTHCARE PROVIDER (HCP) TO ADDRESS THE POSSIBLE OVERDISCHARGE. THE ISSUE OF THE PATIENT NOT BEING ABLE TO CHARGE THE INS BEGAN ABOUT TWO WEEKS AGO IN (B)(6) 2019. THE DEVICE NOT HELPING BEGAN ABOUT 13 MONTHS AFTER THEY WERE IMPLANTED IN 2014. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391361 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 00051 YR