BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4133244 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18114
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 12, 2014
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V914059, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF BLADDER CONTROL. THE PATIENT¿S BLADDER WAS NOT EMPTYING, BUT ALSO NEEDED TO RUN TO THE BATHROOM AND WORE DEPENDS. NO FALLS OR TRAUMAS WERE ASSOCIATED WITH THE EVENT. STIMULATION WAS FOUND TO BE OFF AND WAS TURNED BACK ON DURING THE CALL. STIMULATION WAS OFF DUE TO IT BEING TOO STRONG. STIMULATION WAS DECREASED TO A COMFORTABLE LEVEL. THE PATIENT FELT STIMULATION AT THE IMPLANT SITE. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611017 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR