BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 5611502 · Received April 27, 2016

    Report

    Report Number
    3004209178-2016-08345
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    December 4, 2015
    Report Date
    April 27, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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 MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR FAILED BACK SURGERY SYNDROME AND SPINAL PAIN. IT WAS REPORTED THERE WAS AN IMPEDANCE ISSUE. ALL 7 CONTACTS SHOWED VALUES FROM 10,000-35,000 OHMS, WITH SOME VALUES IN THE 6000-9000 OHMS RANGE USING COMBINATION OF 4,5 AND 6. GROUP IMPEDANCE SHOWED WHEN USING SIMPLE BIPOLE PAIR AS >4000 OHMS, WHICH THIS BATTERY PLATFORM ONLY MEASURES UP TO 4000 OHMS FOR GROUP IMPEDANCE. THE PATIENT WAS NOT FEELING STIMULATION AT 10 VOLTS. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON. THERE WERE NO MEDICAL TESTS OR EMI ENVIRONMENTAL EXPOSURE. THE PATIENT WAS IN FOR NORMAL BATTERY REPLACEMENT. THE REPRESENTATIVE WAS AWARE THAT THERE WERE SOME CONTACTS OUT OF RANGE, BUT BECAUSE OF THE LIMITATIONS OF THE INS IMPEDANCE RANGE, IT WAS HARD TO PINPOINT WHAT MAY BE THE ISSUE. USING THE CLINICIAN PROGRAMMER SHOWED MOST USED PROGRAM WAS A1 @1-2+. THE PATIENT WAS NOT RECEIVING THERAPY BENEFIT. IT WAS NOTED THAT USE OF ANTIBIOTIC SOLUTION COULD POTENTIALLY CAUSE THE IMPEDANCES TO SHOW HIGH BUT WITHIN RANGE OF THE DEVICE. NO IMPEDANCE VALUES WERE OVER 40,000 OHMS, SO NO OPEN CIRCUIT WAS FOUND. IT WAS NOTED THAT IF ANTIBIOTIC SOLUTION WAS THE CAUSE, IT SHOULD RESOLVED OVER TIME AND THE IMPEDANCES SHOULD RETURN TO A NORMAL RANGE. THE REP WOULD FOLLOW UP WITH THE PATIENT POST-OP TO CHECK IMPEDANCES. THE REP WOULD ALSO PROGRAM THE PATIENT WITH SETTINGS THAT HE HAD IN THE PAST TO SEE IF THAT WOULD HELP BRING DOWN IMPEDANCES, AS WELL. STIMULATION WAS NOT FELT IN THE PARESTHESIA AREA. ADDITIONAL INFORMATION RECEIVED FROM A REP REPORTED THAT POST IMPLANT, IMPEDANCES WERE IN THE HIGH RANGE, BUT NOTHING WERE SHOWING GREATER THAN 40K OHMS. THE IMPEDANCES WERE RANGING FROM 10-37K OHMS. REPORTS PATIENT WAS SENT HOME WITH ELECTRODE 4/5/6 AT 5V. IT WAS REPORTED THAT THERAPY IMPEDANCE WAS AT 2908 OHMS. THE PATIENT NEEDED COVERAGE AT RIGHT HIP TO KNEE AREA. REPORTS MULTIPLE REPROGRAMMING HAD BEEN DONE WITH STIMULATION IN RIGHT KNEE TO FOOT AREA. IMPEDANCES HAD COME DOWN SOME, BUT CONTINUED TO BE HIGH. ELECTRODE IMPEDANCE TESTED AT 3V: REFERENCE 0 1: 22904 OHMS 2: 32125 OHMS 3: 29961OHMS 4: 2626 OHMS 5: 27572 OHMS 6: 18210OHMS 7: 24338OHMS REFERENCE 1 0: 22904 OHMS 2: 23599 OHMS 3: 23599 OHMS 4: 14823 OHMS 5: 21935 OHMS 6: 11785 OHMS 7: 19837 OHMS REFERENCE 5: 0: 27572 OHMS 1: 21935 OHMS 2: 27819 OHMS 3: 27092 OHMS 4: 16215 OHMS 6: 12299 OHMS 7: 25747 OHMS REFERENCE 6 0: 18210 OHMS 1: 1175 OHMS 2: 16048 OHMS 3: 16830 OHMS 4: 6171 OHMS 5: 12299 OHMS 7: 12202 OHMS BEFORE THE INS WAS CHANGED OUT, THE PATIENT WAS FEELING STIMULATION IN HIS RIGHT HIP TO KNEE AREA WITH: A1: 1+2- 390PW/65HZ A2: 5+6- 330PW/65HZ A3: 4+5-6+ 390PW/65HZ A4: 1-2+ 360PW/65HZ. REPROGRAMMING DONE USING ELECTRODES: 4/6: PATIENT FEELS STIMULATION AT 3V IN LOWER RIGHT LEG TO FOOT AREA 1-/6+ 2.1V/390PW/65HZ. PATIENT FEELS STIMULATION IN RIGHT LOWER LEG BELOW KNEE 1/4 390PW/65HZ. PATIENT FEELS FAINT STIMULATION LOWER RIGHT LEG AREA, NOT HIP TO KNEE WHERE HE NEEDS COVERAGE 1/0: PATIENT FEELS FAINT STIMULATION AT 2.8V ON RIGHT KNEE BELOW. AN X-RAY HAD NOT BEEN PERFORMED FOR LEAD PLACEMENT. THE PATIENT HAD NOT HAD ANY FALL OR TRAUMA. THE REP WAS SCHEDULED TO SEE THE PATIENT AT 3:30 PM (B)(6). THE PATIENT'S SYSTEM WAS ORIGINALLY IMPLANTED IN GEORGIA. HIS BATTERY REACHED NORMAL END OF LIFE AND THE GENERATOR WAS REPLACED. IN THE PROCEDURE, HE HAD ELEVATED IMPEDANCES BUT THEY THOUGHT IT MAY HAVE BEEN RELATED TO FLUID IN THE AREA. THE PATIENT WAS NOT FEELING STIMULATION AT THE TIME. THE PATIENT WAS HESITANT TO HAVE A REVISION. ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REPORTED THE PATIENT WAS UNABLE TO COMMUNICATE WITH THE INS AND "SOMETHING ABOUT A DISK NOT WORKING." THE HCP NOTED THERE WAS A POSSIBLE REVISION DUE TO THIS ISSUE. TECHNICAL SERVICES ASKED REPEATEDLY FOR CLARIFICATION FOR "ISSUE," BUT WERE UNABLE TO GET A CLEAR ANSWER. IT WAS NOTED THE PATIENT DID NOT BRING THEIR PATIENT PROGRAMMER (PP) TO THE APPOINTMENT, SO THIS MAY HAVE PRECIPITATED THE COMMUNICATION CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268442 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97713

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR