BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3109813 · Received May 13, 2013

    Report

    Report Number
    3004209178-2013-07591
    Event Type
    Injury
    Date Received
    May 13, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# VA03L5P, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# VA03L5P, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID REALLY WELL WITH TEST STIMULATION. THE PATIENT'S THERAPY WAS NOW WORSE THAT HER BASELINE; LOSS OF THERAPEUTIC EFFECT WAS NOTED. THEY HAD TRIED MULTIPLE PROGRAMS. THE HEALTHCARE PROFESSIONAL (HCP) WAS WONDERING WHY TEST STIM WAS GOOD AND IT WAS NOT WORKING NOW. URINE CULTURE WAS CHECKED AND IT WAS NEGATIVE. IMPEDANCE CHECK SHOWED CONTACT 0 WAS SUSPECT. C-0 1164, C-1 448, C-2 765, C-3 565, 0-1 1183, 0-2 2347, 0-3 2347, 1-2 1164, 1-3 925, 2-3 1164 PROGRAMMING AT 0-, 1-, 3+ . IT WAS CHANGED TO 1- <(>&<)> 3+ AND AMPLITUDE OF 2.6 VOLTS. THERAPY IMPEDANCE WAS 925 OHMS. THEY PLANNED TO TRY THIS FOR 2 WEEKS. IT WAS LATER REPORTED ON (B)(6) 2013 THAT THERE WAS NO STIMULATION SENSATION. NEVER HAVING THERAPEUTIC EFFECT WAS NOTED. THE PATIENT HAD GREAT RESPONSE DURING TEST PERIOD BUT HADN'T HAD ANY THERAPY SINCE IPG PLACED. THE PATIENT'S SYMPTOMS WERE THE SAME OR WORSE THAN BASELINE. PREVIOUS IMPEDANCE CHECK INDICATED THAT ELECTRODE #0 WAS SUSPECT ON PROGRAM 2. SINCE THEN, THE PATIENT HAD BEEN USING 1-3+ AT 2.5V. THE PATIENT HAD SOME VAGINAL SENSATION WITH THIS PROGRAMMING FOR A DAY OR TWO AND THEN LOST SENSATION, BUT IT WAS NOTED SHE NEVER GOT ANY THERAPY BENEFIT. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS ISSUE. THE PATIENT'S LOCATION WAS THE CLINIC. CURRENT IMPEDANCE MEASUREMENTS WERE NORMAL. CURRENT IMPEDANCE WERE: C0=765,C1=445, C2=1164, C3=565, 01==1164, 02=2347, 03=1164, 12=1164, 13=1145, 23=1183. THESE WERE NORMAL RANGE, ONLY WITH 02 PAIR AS BEINGSLIGHTLY ELEVATED BUT NOT A CLEAR OPEN CIRCUIT. THEY WERE TO AVOID #0 GIVEN PAST HIGH IMPEDANCES ON #0.THE PATIENT FELT SOMETHING DURING ELECTRODE IMPEDANCE TESTING. THEY WENT UP ON VOLTAGE WITH 1-3+ AND THE PATIENT FELT VAGINALLY.THEY PROGRAMMED C+3-AND THE PATIENT WAS FEELING VAGINALLY AT 1.2V. THEY PLANNED TO TRY THIS FOR ABOUT 2 WEEKS AND THEN HAVE THE PATIENT SEEN AGAIN. IT WAS LATER REPORTED ON (B)(6) 2013 THAT TODAY WHEN CHECKING WITH PROGRAMMER PERCENT USED WAS 100%. THEY HAD DONE MULTIPLE SESSIONS OF REPROGRAMMING AND HAD THE PATIENT COME BACK EVERY TWO WEEKS. TODAY THE PATIENT WAS AT C+, 3- AT 1.2V. THEY ELECTED TO INCREASE STIM TO 2.0V TODAY AND PATIENT WAS FEELING STIM. THEY WERE ABLE TO SYCH WITH PATIENT PROGRAMMER AND SEE NEW PATIENT SETTINGS. THEY PLANNED TO HAVE THE PATIENT COME BACK WITHIN 1-2 WEEKS. IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE CAUSE OF THE EVENT WAS NOTED AS LOSS OF THERAPEUTIC EFFECT AFTER THE IPG WAS PLACED. THE PATIENT HAD VERY GOOD TEST STIM RESPONSE. REGARDING IMPEDANCE MEASUREMENTS IT WAS NOTED THAT LEAD 0 WAS FOUND TO BE SUSPECT. ON (B)(6) 2013 REPROGRAMMING WAS NOTED AS IPG AT PROGRAM 3 , AMP 1.4 AND WAS CHANGED TO 2.1. ON (B)(6) 2013 WAS NOTED AS AMP INCREASED TO 2.6 AND CHANGED TO PROGRAM 2. ON (B)(6) 2013 WAS NOTEDAS PROGRAM 2 LEADS 0,1 NEGATIVE, LEAD 3 POSITIVE, LEAD 0 SUSPECT SO LEAD 0 TURNED OFF LEAD 1 NEGATIVE, LEAD 3 POSITIVE. AMPLITUDE INCREASED TO 2.5. CASE TURNED TO (+), LEAD 3 (-) TODAY (B)(6) 2013. TURNED UP TO AMPLITUDE 2.0 STILL NO IMPROVEMENT. SIGNS AND SYMPTOMS WERE NOTED AS CONTINUED URGE URINARY AND FECAL INCONTINENCE, WORSE THAN PREOP. HOSPITALIZATION WAS NOT REQUIRED. PATIENT OUTCOME WAS NOTED AS NON SERIOUS INJURY/ILLNESS. IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT WAS NOT GETTING ANY THERAPY BENEFIT FOR HER BLADDER AND FECAL INCONTINENCE. THE PATIENT WAS SEEN AGAIN ON (B)(6) AND WAS REPROGRAMMED AGAIN DUE TO LACK OF THERAPY. THEY AVOIDED ELECTRODE #0 AS IN THE PAST IT HAD APPEARED OPEN (THOUGH THIS WASN'T THE CASE WITH #0 WHEN IMPEDANCES MEASURED ON (B)(6)) AND HAVE BEEN USING 1-3+. IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT WENT TO DOCTOR ON MONDAY AND THE STIM WAS NOT ANY BETTER. THE PATIENT WAS WETTING HERSELF AND THIS HAPPENED ON A DAILY BASIS. THE PATIENT CHANGED HER PAD ABOUT 4 TIMES PER DAY. THE PATIENT WAS AT HOME. THE PATIENT HAD SEEN THEIR HCP YESTERDAY BECAUSE OF THE LEAKAGE. IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT WAS STILL HAVING BLADDER AND BOWEL ISSUES. THE PATIENT WAS GOING IN TO THE DOCTOR'S OFFICE EVERY 2 WEEKS TO GET THE INS TO HELP WITH SYMPTOMS. IT WAS NOTED THAT THE PATIENT DIDN'T DO THE TRIAL. SHE HAD 2 PROCEDURES DONE AND WAS NOT SURE WHAT THEY WERE. THE PATIENT WAS ON PROGRAM 2 AT 2.4 AND TURNED UP STIM TO 3.1 THE PATIENT PLANNED TO TRY AT THAT SETTING. THE PATIENT PLANNED TO SEE THEIR HCP ON (B)(6). IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE DOCTOR SAW THE PATIENT ON (B)(6) AND THEY ARE GOING TO REMOVE THE LEAD AND REIMPLANT NEW LEAD UNDER FLUOROSCOPY (B)(6). THE DOCTOR HAD AN OLD X-RAY AND THEN HAD AN X-RAY ON (B)(6) 2013 TAKEN AND COMPARED THE TWO. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID HAVE SURGERY ON (B)(6) 2013 FOR REMOVAL OF THE LEAD AND PLACEMENT OF A NEW LEAD. IT WAS NOTED THAT THE REASON FOR THE REPLACEMENT WAS THE HCP FELT THE LEAD WAS TOO FAR ADVANCED IN THE SACRUM. THE PATIENT RECOVERED FROM PROCEDURE BUT CALLED THE HCP ON (B)(6) TO SAY SHE WAS NOT RECEIVING EFFECTIVE THERAPEUTIC EFFECTS. THE PATIENT WAS REPROGRAMMED BY A MANUFACTURER REPRESENTATIVE ON (B)(6) WITH GOOD RESULTS, AND THE REPRESENTATIVE HAD NOT HEARD BACK FROM THE PATIENT. IT WAS NOTED THAT THE PATIENT WAS ELDERLY AND HAD ISSUES WITH BOTH URINARY AND FECAL INCONTINENCE, AND WAS RECEIVING A 50% REDUCTION IN SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211060 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention