BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2667201 · Received July 24, 2012

    Report

    Report Number
    3004209178-2012-06008
    Event Type
    Malfunction
    Date Received
    July 24, 2012
    Report Date
    June 27, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD: MODEL 3889-28, LOT# V994410, IMPLANTED: (B)(6) 2012, EXPLANTED: NA; PROGRAMMER: MODEL 3037, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION AND NEVER HAD THERAPEUTIC EFFECT. SHE WAS LEAKING AT NIGHT, AND DIDN'T RECALL WHETHER THE TRIAL HAD PROVIDED HER WITH SYMPTOM CONTROL AT NIGHT. THE PATIENT FELT STIMULATION IN THE BUTTOCK AREA ON PROGRAM 4 AT 1.7V, AND CHANGED TO PROGRAM 1 AT 1.6V WHERE THE STIMULATION WAS FELT IN THE PERINEUM AREA. IN THE (B)(6) THE PATIENT WAS INCREASING STIMULATION AND HELD THE INCREASE BUTTON DOWN, BUT ALL OF A SUDDEN THE STIMULATION WAS TOO STRONG AND FELT LIKE A SHOCK. THE PATIENT LIED DOWN AND AT SOME POINT TURNED HER STIMULATION OFF, BUT EXPERIENCED PAIN THE BOTTOM RIGHT SIDE OF HER REAR, WHICH WAS STILL SENSITIVE. THE PATIENT SWITCHED TO PROGRAM 1 AT 2.3V AND PLANNED TO MONITOR HER SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED INDICATED THAT THE PATIENT STILL HAD CONCERNS ABOUT THEIR DEVICE OR THERAPY AND THEY HAD AN APPOINTMENT SCHEDULED FOR (B)(6)-2012. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    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