BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4110948 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17546
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    March 28, 2014
    Report Date
    September 3, 2014
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 889-28, LOT# VA0F2W6, IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A 50 PERCENT OR GREATER SYMPTOM REDUCTION. THE COMPONENT INVOLVED IN THE REPORTED EVENT WAS THE LEAD. TROUBLESHOOTING WAS DONE TO PROVIDE INSIGHT TO THE ISSUE AND ACTIONS WERE TAKEN TO RESOLVE THE ISSUE. THE CAUSE OF THE EVENT WAS NOT DETERMINED AND IT WAS DEVICE RELATED. THE LEAD WAS DAMAGED AND THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF FOR THEIR SURGERY YESTERDAY AND FOR SOME REASON THEY COULDN¿T GET IT TO WORK RIGHT NOW. THE PATIENT SYNCED AND WAS ON PROGRAM 2 WITH STIMULATION ON AT 0.05V AND THE PATIENT USED TO BE AT 4.8V. THE PATIENT TRIED TO INCREASE AND SAW A TRIANGLE AND STEPS GOING UP. THE PATIENT HAD PROGRAM 3 AT 0.0V, PROGRAM 4 AT 0.0V, AND PROGRAM 1 AT 4.8V. THE PATIENT TRIED TO DECREASE STIMULATION BEFORE ACTIVATING PROGRAM 1 BUT WAS NOT SUCCESSFUL. SINCE IMPLANT THE INS HAD CAUSED PAIN IN THE PATIENT¿S BACK SO YESTERDAY, THE INS WAS MOVED TO MORE UNDERNEATH THEIR ARMPIT ABOVE THEIR HIP BUT STILL ON THEIR LEFT SIDE. THE PATIENT REMOVED THAT BATTERIES IN THEIR PROGRAMMER AND THEY WOULD GET NEW BATTERIES AND CALL BACK. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592634 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention