BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2931029 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01022
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 8, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA04V0L, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    AFTER FURTHER REVIEW, THIS EVENT WAS UPDATED TO NOT REFLECT THE SHOCKING ISSUES, AS THIS PERTAINED TO THE PATIENT'S TRIAL; PLEASE REFER TO MFG. REPORT # 3007566237-2013-02084 FOR THE REPORT REGARDING THE TRIAL SYSTEM. THIS REPORT WILL COVER THE ISSUE OF STIMULATION BEING "TOO HIGH" WHEN SWITCHING FROM PROGRAM 1 TO PROGRAM 2. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS DUE TO STIMULATION BEING ¿TOO HIGH.¿ THE EVENT WAS STATED TO BE ATTRIBUTED TO PROGRAMMING. THE PATIENT WAS CURRENTLY USING PROGRAM 1 AT AN AMPLITUDE OF 2.0 VOLTS. THE PATIENT WAS SCHEDULED FOR A FOLLOW-UP APPOINTMENT ON (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY, BUT HAD NOT SOUGHT FURTHER HELP.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NO ISSUES SINCE HAVING THE PERMANENT IMPLANTABLE NEUROSTIMULATOR SYSTEM PLACED. IT WAS CLARIFIED THAT THE ISSUE HAD OCCURRED DURING THE TRIAL PHASE OF THE DEVICE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT DROVE 600 MILES PER DAY AND HAD NOTICED 'SOME IMPROVEMENT.' HOWEVER, THE PATIENT WANTED BETTER CONTROL AND SWITCHED TO PROGRAM 2 AT THE BEGINNING OF THAT WEEK. STIMULATION WAS 'TOO STRONG' AND THE PATIENT NEEDED TO TURN IT DOWN. THE REPORTER INDICATED THAT THE PATIENT WANTED TO TURN STIMULATION OFF AT THE TIME OF THE REPORT AS HE WAS GOING TO HAVE A PROCEDURE DONE. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THE REPORTER STATED THAT THE PATIENT WAS INFORMED IT WAS A "THERAPY NOT A CURE", BUT HAD NOT BEEN INFORMED OF THIS 'RESTRICTION' PRIOR TO BEING IMPLANTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WERE NO DEVICE ISSUES SEEN, NEITHER WERE ANY INTERVENTIONS REQUIRED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36424 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR