BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2904951 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00387
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V307391, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (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

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (MODEL# 3058, SERIAL#N(B)(4)) FOUND NO ANOMALY.

    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 THERE WERE IMPEDANCES GREATER THAN 4,000 OHMS ON SOME BIPOLAR PAIRS. AT 1 VOLT AND 210 PULSE WIDTH INITIALLY EVERYTHING WITH 2 WAS GREATER THAN 4,000. IT WAS RERUN AT 2 VOLTS AND 360 PULSE WIDTH AND FOUND THAT THEY CHANGED THE ONES THAT WERE HIGH. IT WAS NOTED THE LEAD WAS SNUG. THEY PROGRAMMED TO 3-0+ AND PATIENT FELT STIMULATION AT 3.6 VOLTS. THEY COULD NOT GET STIMULATION ON 2-0+ AND THEY WANTED TO TRY A DIFFERENT IMPLANTABLE NEUROSTIMULATOR (INS).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD NOT HAD SYMPTOM RELIEF. ELEVEN DAYS LATER IT WAS STATED THAT THE PATIENT WAS SCHEDULED FOR BOTOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11371 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR