BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3170595 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10397
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 24, 2013
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT # V188958, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MONTH PRIOR TO THE REPORT, THE PATIENT¿S SETTINGS WERE CHANGED BY HER HEALTHCARE PROVIDER (HCP). WHEN THE PATIENT CHECKED THE IMPLANTABLE NEUROSTIMULATOR (INS) STATUS LATER ON, THE PATIENT PROGRAMMER INDICATED THAT IT WAS TURNED OFF. THE REPORTER INDICATED THAT THE PATIENT KNEW SHE DID NOT TURN THE INS OFF ON HER OWN. IT WAS NOTED THAT THE PATIENT¿S TAILBONE HURT AND SHE WANTED TO TURN STIMULATION UP. THE PATIENT REPORTEDLY INCREASED STIMULATION TO 0.3V. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS NOTED THAT AT ONE POINT THE PATIENT ADJUSTED THEIR STIMULATION UP IT WAS TOO HIGH BUT THEY WERE ABLE TO TURN THE STIMULATION BACK DOWN AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271129 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1