BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3181582 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10683
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 20, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3889-28, LOT# VA05V2K, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT# VA038QB, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_PROG, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 3889-28, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: NO ANOMALIES FOUND. FINAL DEVICE ANALYSIS OF THE LEAD REVEALED THE FOLLOWING: NO SIGNIFICANT ANOMALIES FOUND. IT WAS STATED THE LEAD BODY WAS CUT THROUGH.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 ORIGINALLY REPORTED ON (B)(6) 2013 THAT THE PATIENT DID NOT URINATE YESTERDAY AND THIS MORNING IT WAS JUST A TRICKLE. THE PATIENT WOULD INCREASE STIMULATION, BUT COULD NOT FEEL IT. THE PATIENT WAS ON PROGRAM 1 ON THE LEFT SIDE, AND SWITCHED IT TO PROGRAM 2 AT 2.0 V. THE PATIENT WAS ON PROGRAM 3 AT 1.2 V ON THE RIGHT SIDE AND INCREASED STIMULATION TO 2.8 V AND FELT IT NOW. ADDITIONAL INFORMATION RECEIVED SHOWED THE DEVICE HAD BEEN EXPLANTED. DETAILS ABOUT WHY IT WAS REMOVED WERE NOT PROVIDED. NO PATIENT OUTCOME WAS PROVIDED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION FROM THE HEALTHCARE PROFESSIONAL (HCP) CLARIFIED THAT THE PATIENT ONLY HAD ONE INS SYSTEM IMPLANTED. IT ALSO REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2013 WHERE THEIR CURRENT IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPROGRAMMED AND GIVEN NEW SETTINGS <(>&<)> PROGRAMS. THE HCP HAD NOT HEARD FROM THE PATIENT SINCE THIS VISIT AND ADVISED THE PATIENT TOCALL IN A FEW DAYS IF THE STIMULATION WAS NOT EFFECTIVE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD 2 BATTERIES IMPLANTED IN THEIR BUTTOCKS. THE PATIENT DIDN'T HAVE ANY PROBLEMS UNTIL YESTERDAY WHEN THEY WERE UNABLE TO VOID. IT WAS REPORTED THAT THE PROGRAMMER HAD A SCREEN WITH AN I IN A CIRCLE AND ANOTHER CIRCLE WITH TWO ARROWS, ONE POINTING THE LEFT AND ONE POINTING TO THE RIGHT. IT WAS REPORTED THAT THE SCREEN MEANT THE PATIENT NEEDED TO SYNCHRONIZE THEIR PROGRAMMER WITH THEIR DEVICE. IT WAS REPORTED THAT THE PATIENT COULD NOT GET THE PROGRAMMER TO SHUT OFF BUT WAS EVENTUALLY ABLE TO SHUT IT OFF. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE BELIEVED THAT ONE OF THE IMPLANTABLE NEUROSTIMULATOR ( INS) SYSTEMS WAS EXPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S STIMULATOR WAS NOT WORKING AND THEY HAD NOT BEEN ABLE TO URINATE FOR 2 DAYS. THE PATIENT CHANGED THE BATTERIES AND COULD NOT SEEM TO GET IT TO WORK. IT WAS REPORTED THAT THE PATIENT'S SECOND IMPLANT FAILED AND ONLY HAD ONE IMPLANT NOW. THE PATIENT HAD BEEN SWITCHED TO PROGRAM 3 A COUPLE OF MONTHS AGO AND WAS ON PROGRAM 1 BEFORE THAT. IT WAS NOTED THAT THE PATIENT HAD NOT TRIED PROGRAM 2 OR PROGRAM 4. THE PATIENT HAD A STROKE MONTHS AGO IN AUGUST AND THEY SHUT THE MACHINE OFF. IT WAS REPORTED THAT WHEN THE DEVICE WAS TURNED BACK ON THEY WERE ABLE TO FEEL IT. THE PATIENT WAS ON PROGRAM 3 AT 3.5V WITH THE LIGHTNING BOLT AND COULD NOT FEEL THE STIMULATION. AFTER INCREASING STIMULATION THE PATIENT REACHED THE UPPER LIMIT OF 6.0V STILL DIDN'T FEEL ANYTHING. IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION BECAUSE THE UPPER LIMIT WAS REACHED. THE PATIENT SWITCHED TO PROGRAM 4 AND WAS ABLE TO GO AS HIGH AS 6.0V WHEN THEY GOT THE UPPER LIMIT ARROW. IT WAS REPORTED THAT THE PATIENT GOT A SHOCK. THE PATIENT WAS ABLE TO TURN THE STIMULATION DOWN AND OFF BUT IT TOOK A COUPLE OF TIMES BECAUSE THE PATIENT WAS IN PAIN. IT WAS NOTED THAT THE PATIENT DID NOT FEEL THE STIMULATION AS THEY WERE INCREASING IT. IT WAS ALSO NOTED THAT THE PATIENT HAD ADVANCED CARDIAC DISEASE AND COULD NOT BE STRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282259 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention