BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4555184 · Received February 27, 2015

    Report

    Report Number
    3004209178-2015-03863
    Event Type
    Malfunction
    Date Received
    February 27, 2015
    Report Date
    February 5, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3 095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-28, LOT# V875083, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND THEY HAD DIARRHEA THAT WOULDN¿T STOP FOR THREE WEEKS. THE PATIENT STATED THAT THEIR THERAPY HAD BEEN FINE UNTIL RECENTLY AND THE SYMPTOMS HAD A SUDDEN ONSET. THE PATIENT STATED THEY HAD TWO REMOTES AND THEY WERE ON PROGRAM 2 AT 2.0 VOLTS AT THE TIME OF REPORT. THE PATIENT INCREASED THEIR STIMULATION. NO INTERVENTIONS OR OUTCOME WERE REPORTED RELATED TO THIS EVENT. ADDITIONAL FOLLOW UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138821 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR