BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3180803 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10666
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 748910, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-28, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_STIMBOOT_ACC, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 748910, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEUROSTIMULATOR, SERIAL #(B)(4), FOUND THE BATTERY WAS NOT IN NEW CONDITION WITH NO SIGNIFICANT ANOMALIES. ANALYSIS OF THE EXTENSION, SERIAL #(B)(4), FOUND NO ANOMALY. ANALYSIS OF THE BOOT FOUND IT CUT WITH NO SIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT, THE SURGEON WANTED TO CHANGE THE EXTENSION AS IT WAS ¿TWISTED AROUND THE LEAD¿. WHEN THE LEAD WAS REMOVED FROM THE EXTENSION BARREL, IT WAS NOTICED THAT THE OUTER INSULATION OF THE LEAD HAD ¿BROKEN¿ VERY ¿CLEANLY¿ WHERE THE ELECTRODE 0 (THE CONTACT CLOSEST TO THE TINES AT THE NON-STIMULATION END OF THE LEAD) JOINED THE OUTER LEAD INSULATION. THE SURGEON DETERMINED THAT THIS COULDN¿T HAVE BEEN DUE TO FLEXION OF THE LEAD, AS THE POINT OF SEPARATION WOULD HAVE BEEN WITHIN THE BARREL OF THE EXTENSION. ADDITIONALLY, THE ¿BREAK¿ WAS NOT UNDER THE SUTURE POINT OF THE BOOT. THE SURGEON DETERMINED THAT THE BREAK MUST HAVE BEEN DUE TO DISTRACTION FORCES AND WONDERED IF IT WAS JUST A ¿FAULT¿ WITH THE LEAD AS IT WAS ORIGINALLY IMPLANTED IN 2007 AND THAT WAS THE PATIENT¿S SECOND BATTERY REPLACEMENT. THE REPORTER INDICATED THAT THERE HAD BEEN NO COMPLAINTS OF ANY ADVERSE STIMULATION. ALTHOUGH THE PATIENT FELT THE STIMULATION WAS A ¿BIT WEAKER¿ ¿POSSIBLY DUE TO THE FACT THAT THE BATTERY HAD LESS THAN 20% POWER REMAINING, THE PATIENT WAS STILL RECEIVING BENEFIT FROM THE THERAPY. AN IMPEDANCE TEST WAS NOT DONE PRIOR TO THE PROCEDURE AS IT DID NOT APPEAR TO BE INDICATED. THE REPORTER INDICATED THAT THE SURGEON HAD NOT CONSENTED THE PATIENT TO A LEAD REMOVAL SO THE LEAD WAS NOT REMOVED BUT NOTED THAT IT WAS GOING TO BE DONE IN THE ¿NEXT FEW WEEKS¿. THE INS AND EXTENSION WERE HOWEVER REPLACED. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA. APPROXIMATELY A WEEK LATER, IT WAS REPORTED THAT THE SURGEON DID NOT USE THE SUTURE HOLES. UNFORTUNATELY, THERE WERE NO X-RAYS OR IMAGES TAKEN AS IT WAS TO BE A STRAIGHT INS REPLACEMENT AND THE TWISTING WAS NOT SEEN BY THE REPORTER. THE REPORTER INDICATED THAT THE INS WAS SITED IN THE PATIENT¿S BUTTOCK AND DID NOT THINK THAT IT WAS A TWIDDLER¿S SYNDROME INCIDENT. THE REPORTER DID NOT HAVE ANY THOUGHTS ON HOW THIS OCCURRED. IT WAS LATER REPORTED THAT THE PATIENT¿S NEW INS, EXTENSION AND ¿OLD¿ LEAD WERE SWITCHED ON 1-,2+, 1.1V, 210MCS, 14HZ. THE PATIENT WAS COMFORTABLE ON THESE SETTINGS AND COULD FEEL STIMULATION. NO IMPEDANCE TEST WAS COMPLETED. THE REPORTER INDICATED THAT THE SURGEON STILL INTENDED TO REPLACE THE LEAD ¿SOMETIME IN THE FUTURE, PERHAPS IN ABOUT 6 MONTHS¿. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281500 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1