BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3813176 · Received May 15, 2014

    Report

    Report Number
    3007566237-2014-01333
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT# V021931, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS ((B)(4)) FOUND NO ANOMALY. A KNOWN GOOD LEAD WAS ATTACHED TO THE RETURNED INS AND THE INS AND THE DISTAL END OF THE LEAD WERE PLACED IN A 0.9% SALINE SOLUTION. USING A CLINICIAN PROGRAMMER, IMPEDANCES WERE MEASURED AND NORMAL IMPEDANCES WERE MEASURED ON ALL CIRCUITS AND ELECTRODE PAIR COMBINATIONS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS FILED AS MFR REPORT # 3007566237-2014-01333. ADDITIONAL REVIEW INDICATED THE CORRECT MANUFACTURING SITE WAS SITE 3004209178. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS IN A CASE TO DO A SIMPLE BATTERY REPLACEMENT AND THEY KNEW THE LEAD WAS GOOD AS THEY USED A SCREENING KIT TO TEST MOTOR RESPONSE AND SENSORY RESPONSE ON THE LEAD. THEY TESTED ALL 4 ELECTRODES AND THEY WERE GOOD, HOWEVER WHEN CONNECTING WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) THEY GOT ABNORMAL IMPEDANCES ON AT LEAST 8 OUT OF 10 ELECTRODES AND THEY WERE GETTING GREATER THAN 4000 OHMS IMPEDANCE MEASUREMENTS. IT WAS NOTED THAT THEY TESTED THE ELECTRODE IMPEDANCE MEASUREMENTS AT 1.5V AT 270 MICROSECONDS AND AT 2.0V AT 330 MICROSECONDS. THERE WAS NO C-ARM IN THE ROOM AND THEY TURNED OFF THE FLUORESCENT LIGHTS AS WELL IN CASE THAT WAS INTERRUPTING THE CLINICIAN PROGRAMMER TELEMETRY. IT WAS REPORTED THAT THEY ALSO OPENED UP A SCREENER CABLE AND GOT BELLOW AND TOES ON ALL 4 ELECTRODES. THEY RECOMMENDED THAT THE HEALTH CARE PROVIDER (HCP) GIVE A GENTLE TUG ON THE LEAD TO SEE IF THE LEAD WAS SEATED PROPERLY WITH THE SETSCREW DOWN AND THAT WAS CONFIRMED TO BE OKAY AND THE LEAD WAS SEATED DOWN FINE. IT WAS NOTED THAT THEY HAD DISCONNECTED AND RECONNECTED NUMEROUS TIMES WITHOUT RESOLVE OF HIGH IMPEDANCE VALUES. THE HCP CONFIRMED VISUALLY THAT EVERYTHING WAS SEATED AND THEY ALSO TRIED RESTARTING THE CLINICIAN PROGRAMMER. IT WAS REPORTED THAT THEY TRIED 1 MORE ELECTRODE IMPEDANCE TEST AT 3.0V AND 330 MICROSECONDS AND DURING THIS TEST THE PATIENT WAS FEELING STIMULATION AND HAD TOE RESPONSE AND BELLOW RESPONSE AND C0 WAS GREATER THAN 4000 OHMS. THEN THEY PROCEEDED TO TRY MOTOR RESPONSE TESTING WITH THE NEUROSTIMULATOR CONNECTED TO THE LEAD AND THE MANUFACTURER REPRESENTATIVE WANTED TO KNOW IF THEY SHOULD REPLACE THE INS. IT WAS NOTED THAT THE LEAD WAS ROUGHLY 7 YEARS OLD AND DURING THE PROCEDURE THE HCP OPTED TO REPLACE THE INS BATTERY TO RULE OUT THE INS ISSUE. WHEN THEY PLACED THE SECOND BATTERY THEY GOT THE SAME IMPEDANCE RESULTS AND NOTHING CHANGED SO THE DECISION WAS MADE TO CLOSE. IT WAS REPORTED THAT POST-OPERATIVELY IN RECOVERY THEY RAN THE IMPEDANCE TEST AND GREATER THAN 4000 OHMS WAS SEEN ON ALL CONTACTS EXCEPT C1, C1, 12, AND 21 WERE OKAY. THE MANUFACTURER REPRESENTATIVE WAS ABLE TO SETUP 4 PROGRAMS ON THESE ELECTRODE COMBINATIONS AND THE PATIENT WAS FEELING STIMULATION IN THE RIGHT AREA. IT WAS NOTED THAT PATIENT FELT VAGINAL STIMULATION AT AROUND 1.4V TO 2.1V. THE HCP HAD DONE IMPEDANCE TESTING PRIOR TO THE PROCEDURE AND THE IMPEDANCE ISSUE WASN¿T PRESENT PRIOR TO THE PROCEDURE WHICH WAS WHY THE PATIENT WAS ONLY SCHEDULED FOR A BATTERY REPLACEMENT PROCEDURE. IT WAS NOTED THAT THEY WOULD SEE IF THE PATIENT GOT THERAPEUTIC BENEFIT ON THE VIABLE CONTACTS AND THE BATTERY WOULD BE SENT BACK FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO LEAD FRACTURES WERE NOTED. THE PATIENT DID RECEIVE A NEW BATTERY AS THEIR PREVIOUS INS HAD REACHED END OF SERVICE. IT WAS NOTED THAT THE PATIENT WAS LEFT WITH 4 WORKING PROGRAMS AND NO OTHER INTERVENTIONS WERE NECESSARY. THE PATIENT OUTCOME WAS GOOD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE NOW HAD THE DEVICE IN THEIR POSSESSION AND WOULD SEND IT BACK NEXT WEEK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WOULD BE IN THE MAIL IN 2 DAYS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THEY COULD NOT GET NORMAL IMPEDANCES. IT WAS NOTED THAT THERE WAS NO PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290923 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR