BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3821492 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09285
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    April 25, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF INTERSTIM II S/N (B)(4) FOUND INSIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V340505, IMPLANTED: (B)(6) 2009, 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 THEIR DEVICE EXPLANTED ON THE DAY OF THE REPORT. IT WAS NOTED THAT THE PRODUCT WAS NOT REPLACED AND THE DEVICE WOULD BE RETURNED. THE PATIENT EXPERIENCED STIMULATION OR THERAPY ISSUES OF A LOSS OF THERAPEUTIC EFFECT AND THE RESULT OF THE EVENT WAS EXPLANT. IT WAS REPORTED THAT IT WAS UNKNOWN IF ANY DIAGNOSTIC TESTING OR TROUBLESHOOTING HAD BEEN PERFORMED AND WAS UNKNOWN IF THE ISSUE WAS RESOLVED OR IF THE CAUSE OF THE ISSUE WAS DETERMINED. THEY WERE UNABLE TO OBTAIN THE PATIENT STATUS AT THE TIME OF REPORT AND IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNKNOWN HOW THE PATIENT WAS DOING NOW. THE HOSPITAL STILL HAD THE PATIENT¿S DEVICE AND THE MANUFACTURER REPRESENTATIVE WOULD SEND IT BACK WHEN THEY RECEIVED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299784 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention