BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2495298 · Received March 19, 2012

    Report

    Report Number
    3004209178-2012-01659
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Report Date
    February 22, 2012
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3093-28 LOT# V840219 IMPLANTED (B)(6) 2011 EXPLANTED UNK; PROGRAMMER MODEL 3037 SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALWAYS HAD SOME THERAPEUTIC EFFECT, BUT THEN IT WOULD GO AWAY. AT THE TIME OF REPORT THE PATIENT WAS NOT FEELING STIMULATION SENSATION. UPON INTERROGATION WITH THE PATIENT PROGRAMMER, THE NEUROSTIMULATOR WAS DETERMINED TO BE OFF. THE NEUROSTIMULATOR WAS TURNED ON AND WAS ON PROGRAM 1 AT 1.15 VOLTS, AND THE PATIENT FELT PAIN. THE PATIENT TURNED THE NEUROSTIMULATOR OFF AND DECREASED STIMULATION DOWN TO 0.0 VOLTS. AFTER TURNING IT BACK ON AND INCREASING IT TO 0.6 VOLTS, THE PATIENT FELT SLIGHT STIMULATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PHYSICIAN WANTED THE PATIENT TO TURN THE IMPLANTABLE NEUROSTIMULATOR OFF AND JUST USE BOTOX TO SEE IF HER SYMPTOMS WOULD IMPROVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1