BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2704336 · Received August 17, 2012

    Report

    Report Number
    3004209178-2012-07020
    Event Type
    Injury
    Date Received
    August 17, 2012
    Report Date
    July 20, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD: MODEL 3889-28, LOT# V933650, IMPLANTED: 2012 (B)(6), EXPLANTED: NA; PROGRAMMER MODEL 3037, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PREPARING TO UNDERGO AN MRI OF HER BACK DUE TO NUMBNESS AND TINGLING. THE PATIENT HAD EXPERIENCED BACK ISSUES SINCE 2004, AND HAD BEEN EXPERIENCING A SCIATIC ISSUE FOR THE LAST FOUR MONTHS. AT NIGHT THE TINGLING AND NUMBNESS EVEN CARRIED OVER TO THE LEFT LEG, AND THE PATIENT COULD HARDLY WALK. SHE TRIED TURNING STIMULATION OFF BUT THAT DIDN'T REALLY AFFECT HER BACK ISSUES. IT WAS NOTED THAT THE PATIENT FELT THE SYMPTOMS IN HER BACK HAD GOTTEN WORSE SINCE SHE HAD INS IMPLANTED. THE PATIENT FELT THE INTERSTIM THERAPY WAS HELPING SOMEWHAT, BUT SHE STILL HAD SOME "DRIPPING" AND FELT SOMETHING MIGHT BE PUTTING PRESSURE ON THE AREA. SHE TRIED INCREASING STIMULATION WITHOUT IMPROVEMENT AND STATED THAT HER HCP TOLD HER TO ONLY USE THE PROGRAM SHE WAS ON. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 Other