BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3931524 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12946
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 23, 2014
    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
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0FSSX, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: NEU KNOWN PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND HAD A SUDDEN RETURN OF SYMPTOMS 2 WEEKS AGO. IT WAS NOTED THAT THE RETURN OF SYMPTOMS WAS ONLY FOR THE PATIENT¿S BOWELS AND NOT THEIR BLADDER AS THE PATIENT HAD THE DEVICE FOR BOTH. THEY CHECKED THE PATIENT¿S IMPLANT AND IT WAS DETERMINED THAT THE IMPLANT WAS OFF EVEN THOUGH THE PATIENT SAID THEY WERE FEELING STIMULATION. IT WAS REPORTED THAT THE DEVICE WAS OFF SET ON PROGRAM 1 AT 3.7V AND THE DEVICE WAS TURNED BACK ON AT 2.0V AND THE PATIENT COULD ACTUALLY FEEL IT. IT WAS NOT KNOWN IF THEY DECIDED TO TURN STIMULATION BACK UP TO 3.7V. IT WAS NOTED THAT THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTH CARE PROVIDER (HCP) DID NOT SEE THE PATIENT ON 2014-(B)(6) FOR TROUBLE WITH THEIR DEVICE. THE PATIENT NEVER REPORTED ANY TROUBLE TO THEM. IT WAS NOTED THAT THEY SAW THE PATIENT ON 2014-(B)(6) AND THEY HAD NO COMPLAINTS AND THEY WERE NOT SURE WHO REPORTED THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409098 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1