BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3183194 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10738
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    June 3, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# VA08EZP, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

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¿S TRIAL WAS SUCCESSFUL WITH 50% OR BETTER EFFICACY. SINCE IMPLANT, THE PATIENT HAD GOTTEN 0% EFFICACY. THE PATIENT HAD HER NEXT APPOINTMENT IN JUST OVER THREE WEEKS. FOLLOW-UP INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD CONCERNS REGARDING HER DEVICE OR THERAPY AND RECEIVED ASSISTANCE FROM HER MANUFACTURER REPRESENTATIVE AND SUGGESTIONS WERE OFFERED. IT WAS NOTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HER DEVICE OR THERAPY, BUT HAD NOT SEEN HER DOCTOR YET. AN APPOINTMENT DATE OF (B)(6) WAS NOTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A PATIENT HAD THE DEVICE REMOVED BECAUSE IT DIDN'T WORK FOR HER. IT WAS NOTED THAT THE PATIENT HAD THE DEVICE FOR THE BLADDER AND HAD "20 OTHER PROCEDURES THAT DIDN'T WORK" AND SHE NEEDED A "NEW BODY." IT WAS REPORTED THAT THE PATIENT HAD TRIED BOTOX, PILLS, PATCHES, AND INJECTIONS AND NOTHING WORKED. THE REPORTER STATED THAT THE PATIENT WAS IMPLANTED ON (B)(6) 2014 AND APPROXIMATELY FOUR MONTHS AFTER IMPLANT THE PATIENT HAD THE DEVICE REMOVED BECAUSE IT DIDN'T WORK FOR HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283874 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR