BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4325380 · Received December 12, 2014

    Report

    Report Number
    3004209178-2014-23835
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Report Date
    November 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V940070, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD KNEE REPLACEMENT SURGERY TWO DAYS BEFORE REPORTED EVENT DATE. THE NIGHT BEFORE REPORTED EVENT DATE, WHEN HE WENT TO TURN STIMULATION ON HE WAS UNABLE TO DO SO. THE PATIENT¿S FAMILY MEMBER REPORTED SHE DOESN'T KNOW IF THE PATIENT TURNED STIMULATION OFF BEFORE SURGERY AND THE LAST TIME HE USED PROGRAMMER WAS PROBABLY ONE MONTH AGO. CALLER REPORTS NOT BEING ABLE TO MAKE ADJUSTMENT BOTH WITH OR WITHOUT ANTENNA ATTACHED. THE PATIENT FAMILY MEMBER SAID THAT THEY WERE NOT TOLD TO ¿PROGRAMMER TO PROCEDURE¿ OR TURN DEVICE OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807413 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR