BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4490196 · Received February 6, 2015

    Report

    Report Number
    3004209178-2015-01891
    Event Type
    Malfunction
    Date Received
    February 6, 2015
    Report Date
    January 13, 2015
    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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3889-28, LOT# V142990, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# V142990, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. PRIMARY REASON FOR CALL WAS TO ASK ABOUT ELECTROCAUTERY PRIOR TO A SURGICAL PROCEDURE AND ABOUT USING THE PROGRAMMER TO TURN THE IMPLANT OFF. THE PATIENT DIDN'T BRING CONTROLLER WITH HER AND WAS GOING FOR SURGERY. AT THE TIME OF THE CALL, THE CALLER MENTIONED THAT THE PATIENT REPORTS THE NEUROSTIMULATION SYSTEM NEVER WORKED, AND THE PATIENT DOESN'T USE IT ANYMORE. 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
    87046 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1