BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5068632 · Received September 10, 2015

    Report

    Report Number
    3004209178-2015-17748
    Event Type
    Injury
    Date Received
    September 10, 2015
    Report Date
    August 19, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 093-28, LOT# V875083, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT'S SYMPTOMS RETURNED AND THE CAUSE OF THE EVENT WAS UNKNOWN AS NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER REPRESENTATIVE FURTHER REPORTED THAT REPROGRAMMING WAS ATTEMPTED BY THE OFFICE AS A TROUBLESHOOTING MEASURE AND SURGICAL INTERVENTION OCCURRED AS A RESULT OF AN EXPLANT. THE ISSUE RESOLVED AT THE TIME OF THE REPORT. THE PATIENT'S MEDICAL HISTORY WAS UNABLE TO OBTAIN AND THE STATUS OF THE PATIENT AT THE TIME OF REPORT WAS "ALIVE- NO INJURY". THE ISSUE OCCURRED DURING NORMAL USE AND THE INDICATIONS FOR USE WERE URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. FURTHER FOLLOW- UP IS BEING CONDUCTED TO OBTAIN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW- UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598562 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention