BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3883825 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-11802
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA0G7Q6, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SPASMS IN BOTH LEGS. THE ISSUE STARTED APPROXIMATELY 2.5 WEEKS AGO. THE SPASMS OCCUR WHEN THE PATIENT WAS TRYING TO SLEEP WHEN STIMULATION IS ON. THE PATIENT TRIED TO TURN STIMULATION DOWN AND IT HELPED SOME, BUT THEN HER FREQUENCY INCREASED THROUGHOUT THE DAY. THE PATIENT DECREASED STIMULATION FROM 0.6VOLTS TO 0.4VOLTS, AND THEN THE PATIENT INCREASED BACK TO 0.5VOLTS (ON PROGRAM 1). THE PATIENT HAD BEEN ON THE SAME PROGRAM AND HER HEALTHCARE PROVIDER (HCP) NEVER MENTIONED CHANGING PROGRAMS. THE PATIENT WAS TOLD BY HER HCP THAT THE MANUFACTURER WOULD KNOW WHAT TO DO. IT WAS ALSO STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD MOVED IN THE POCKET SINCE IMPLANT. THE PATIENT NOTIFIED HER HCP ABOUT THE ISSUE, BUT THE HCP WAS ¿FOR THE MOST PART SATISFIED WITH IT.¿ IT WAS FURTHER STATED THAT THE INS COULD BE FELT AT NIGHT STICKING OUT, WHICH WAS PAINFUL IN CERTAIN POSITIONS. THE PATIENT EVEN EXPERIENCED TROUBLE COMMUNICATING SOMETIMES DUE TO THE ISSUE. IT WAS MENTIONED THAT THE PATIENT SOMETIMES RECEIVED THE POOR COMMUNICATION SCREEN. IT WAS NOTED THAT THE PATIENT HAD 3 SURGERIES (HYSTERECTOMY (B)(6) 2013, SCHEDULED TO HAVE UTERINE ABLATION IN (B)(6) 2013 (HCP DECIDED AGAINST IT), AND RECONSTRUCTIVE SURGERY ON STOMACH DUE TO HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362038 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR