BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7575803 · Received June 6, 2018

    Report

    Report Number
    3004209178-2018-12799
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    March 2, 2018
    Report Date
    June 6, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    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 BY A MANUFACTURE REPRESENTATIVE (REP) VIA A HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. THE MANUFACTURING REPRESENTATIVE REPORTED THE PATIENT WAS AT LOWER SETTINGS 210 14HZ JUST TURNED UP TO 1.5 AND SEEING 29% AND 27-48MONTHS INS LEFT. THE REPRESENTATIVE WOULD GET IMPEDANCES FROM DOCTOR. CALLER WILL SEE IF PT CHANGES PROGRAMS OFTEN OR STAYS ON ONE FOR AN ACCURATE BATTERY MEASUREMENT. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). CALLER REPORTED THAT THEY HAD ELECTRODE IMPEDANCE TESTING: C0: 1016 OHMS, C1: 1016 OHMS, C2: 1016 OHMS, C3: 516 OHMS, 01: 1016 OHMS, 02: 1049 OHMS, 03: 1016 OHMS, 12: 1016 OHMS, 13: 1016 OHMS, 23: 1016 OHMS, THEY REVIEWED POSSIBLE SHORT, REPROGRAMMING AND X-RAY BUT NO INFORMATION. ADDITIONAL INFORMATION FROM THE MANUFACTURE REPRESENTATIVE (REP) ON (B)(6) REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY LEVEL WAS AT 30%-50% FULL AFTER ONLY BEING IMPLANT APPROXIMATELY 6 MONTHS. THE REP NOTED X-RAYS HAD BEEN TAKEN AND THERE WERE NO BENDS, TWIST OR KINKS SEEN. THE REP NOTED IMPEDANCES WERE TAKEN AND NO SHORT CIRCUITS WERE SEEN EITHER. IT WAS NOTED THE PATIENT WAS USING AMPLITUDE AT 0.5-0.6 V. THE REP NOTED THERE WERE NO TROUBLE SHOOTING/INTERVENTIONS DONE ON THE DATE OF THE CALL. THE REP STATED THE REASON FOR THE CALL WAS TO SPEAK WITH SOMEONE ABOUT REIMBURSEMENT FOR A FAULTY DEVICE IN THE PATIENT¿S OPINION. THE PATIENT NOTED IT WAS AROUND (B)(6) WHEN THE ISSUE WAS FIRST NOTICED. THE HEALTHCARE PROFESSIONAL (HCP) IN THE CLINIC USED A CLINICIAN PROGRAMMER TO GET RESULTS. THE PATIENT STATED SHE HAD RELIEF OF SYMPTOMS AND AFTER ABOUT TWO MONTHS SHE SAID IT DIDN¿T WORK AS WELL. THE PATIENT WAS GOING TO TRY NEW PROGRAM THAT SHE HADN¿T TRIED BEFORE, BUT THAT WOULDN¿T HELP HER BATTERY LIFE ISSUE. ADDITIONAL INFORMATION FROM THE REP ON (B)(6) REPORTED ALL IMPEDANCES VALUES WERE 1458 OHMS. THE REP NOTED THE REASON FOR THE CALL WAS CONCERN OVER THE BATTERY DEPLETION RATE. THE REP STATED THAT WITH THE CURRENT PROGRAM THE BATTERY TEST WAS SHOWING 29-50% BATTERY REMAINING. THE REP NOTED SHE WAS WITH THE PATIENT AGAIN AND WHEN THE IMPEDANCES WERE RUN ALL BIPOLAR PAIRS SHOWING IMPEDANCE VALUE OF 1458 OHMS. THE REP STATED THAT SHE TURNED UP THE AMPLITUDE TO 1 V AND THE PULSE WIDTH WAS 300 US TO RUN THE IMPEDANCE TEST. THE REP RAN THE IMPEDANCE TEST AGAIN AT 1.5 V AND 300 US AND THE FOLLOWING RESULTS WERE SEEN CONTACT 0 1094, CONTACT 1 1094, CONTRACT 2 1077, CONTACT 3 721, 01 1231, 02 2202, 03 1189, 13 1112, 23 1094. THE REP STATED ON PROGRAM 2 THE SETTINGS WERE 1-3+ 0.5 V 210US 14 HZ WITH AN IMPEDANCE OF 1112 OHMS, AND AN ESTIMATED BATTERY LIFE OF 28-49 MONTHS. THE REP NOTED ON PROGRAM 1 AT 0.7 V THERE WAS AN IMPEDANCE OF 1254 OHM WITH AN ESTIMATED BATTERY LIFE OF 28-48 MONTHS. THE REP STATED ON PROGRAM 3 AT 0.6 V THE IMPEDANCE WAS 1466 OHMS AND ON PROGRAM 4 AT 1.5 V THE IMPEDANCES WAS 1130 OHMS. IT WAS NOTED THE PATIENT WAS NOT EXPERIENCING ANY SHOCKING SENSATION. THE PATIENT DID NOT HAVE CYCLING ACTIVE AND THE BATTERY WAS NOT SUPERFICIAL. THE REP STATED THAT SHE WASN¿T ON PROGRAM 2, BUT PROGRAM TO PROGRAM 1 IN THE PAST FEW WEEKS. THE REP STATED THAT THERAPY HADN¿T BEEN WORKING AS WELL, WHICH WAS SOMETHING THAT PROMPTED THE CALL. THE REP STATED THE PATIENT HAD A THERAPY CHANGED THAT BEGAN A COUPLE OF MONTHS AGO AND SHE WAS NOTIFIED AT THE TIME OF THE CALL WHERE SHE PROVIDED IMPEDANCES ON (B)(6). THE REP STATED THE PATIENT DID NOT ADJUST THE INTENSITY BECAUSE THE PATIENT FELT STIMULATION INCREASING INTENSITY WAS UNCOMFORTABLE. ADDITIONAL INFORMATION FROM THE CONSUMER ON (B)(6) REPORTED AFTER THE DEVICE WAS IMPLANT SHE HAD 2 MONTHS OF SYMPTOM RELIEF THEN THE ¿COVERAGE¿ WAS NOT GOOD. THE PATIENT STATED SHE HAD ALWAYS BEEN ABLE TO BE ON ONE PROGRAM AND AT A LOW SETTING. THE PATIENT STATED SHE WAS GOING TO THE BATHROOM 2-3 TIMES AN HOUR. THE PATIENT STATED SHE ALSO DEALT WITH CHRONIC BACK PAIN WHICH TAKES HER OUT OF WORK. THE PATIENT STATED SHE WAS ALLERGIC TO PAIN MEDICATION AND SHE BREAKS OUT IN HIVES. THE PATIENT STATED SOMETIMES THE STIMULATION GOT PRETTY INTENSE IN HER LEGS. THE PATIENT NOTED SHE DIDN¿T FEEL STIMULATION A TON. THE PATIENT NOTED SHE HADN¿T ALWAYS BEEN ABLE TO DRINK A TON OF WATER DURING THE DAY, BUT SOMETIMES SHE WOULD BE TOO DEHYDRATED FOR SURGERY. THE PATIENT STATED IN THE LAST MONTH OR SO SHE HAD BEEN DRINKING MORE WATER (4-6 GLASSES). THE PATIENT STATED THE INCREASE IN WATER INTAKE MAY BE WHY SHE WAS GOING TO THE BATHROOM MORE OFTEN. THE PATIENT STATED SHE MAY TRY TURNING STIMULATION OFF AND SEEING HOW OFTEN SHE FOES WHEN STIMULATION ISN¿T ON TO SEE IF IT WAS HELPING 50%. THE PATIENT STATED HER SYMPTOMS WERE BETTER THAN THEY WERE BEFORE SHE GOT THE DEVICE, BUT NOT AS GOOD AS THEY WERE THE FIRST 2 MONTHS AFTER THEY HAD THE DEVICE. THE PATIENT STATED WHEN HER IMPLANT WAS CHECK IN MARCH IT SHOWED ONLY 20-50% BATTERY LEFT. IT WAS RECOMMENDED THE PATIENT CHECK FOR THE LOW BATTERY MESSAGE AND CONTACT HER HCP AS SOON AS SHE SEES IT. IT WAS ALSO RECOMMENDED THE PATIENT TRY THE 2 NEW PROGRAM SHE WAS GIVEN AND CONTACT THE HCP IF THE SYMPTOMS DIDN¿T IMPROVE. THE PATIENT STATED SHE DIDN¿T FEEL LIKE THERE WAS ANY HELP FROM HER HCP OR THE REP UNTIL SHE SAID SOMETHING THE BATTERY DEPLETION NOT BEING RIGHT. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT SAID SHE RUNS HER PROGRAM AT A VERY LOW SETTING (UNDER 1.0) AND THE BATTERY DEPLETION IS CLEARLY A DEVICE ISSUE. IT WAS NOTED THAT THE DEVICE FOR HER BACK SHE RUNS AT A VERY HIGH RATE AND IT IS RECHARGEABLE. THE PATIENT HAS HAD ISSUES IN THE PAST BUT THIS TIME IT IS DIFFERENT. THE PATIENT FEELS THE PROGRAM SHE HAS BEEN ON IS A LITTLE MORE EFFECTIVE. THE PATIENT WAS GOING TO TURN THE STIMULATION OFF AND JOURNAL HER SYMPTOMS. SHE HAS BEEN GOING TO THE BATHROOM QUITE A BIT MORE AT NIGHT AND DURING THE DAY. SHE WAS GOING TO TURN THE STIMULATION OFF THEN BACK ON AND TRACK SYMPTOMS TO SEE IF SHE IS GETTING A 50% OR GREATER REDUCTION IN SYMPTOMS. THE PATIENT NOTED THAT IF SHE ISN'T, SHE WILL SEE HER HEALTHCARE PROFESSIONAL (HCP) SOONER THAN 6 MONTHS. IT WAS REVIEWED WITH THE PATIENT THAT SHE SHOULD ALSO LOOK FOR LOW BATTERY MESSAGE AND FOLLOW UP WITH HER HCP WHEN SHE SEES IT. THERE WERE NO FURTHER COMPLICATIONS OR ANTICIPATIONS REPORTED WITH THIS EVENT. ADDITIONAL INFORMATION FROM THE REP REPORTED SHE WAS AWARE OF THE ALLEGATION OF THE EARLY BATTERY DEPLETION ON (B)(6) WHEN THE HEALTHCARE PROFESSIONAL (HCP) TOLD HER OF THE CONCERN. IT WAS NOTED THERE WAS X-RAYS TAKEN IN (B)(6) 2018 THAT LOOKED NORMAL AND THE PATIENT DENIED ANY FALLS. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415909 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR