BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5065347 · Received September 9, 2015

    Report

    Report Number
    3004209178-2015-17620
    Event Type
    Injury
    Date Received
    September 9, 2015
    Report Date
    June 28, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V945725, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REPLACEMENT/REVISION OCCURRED. THE EVENT BEING REPORTED WAS A LEAD ISSUE OF MIGRATION/DISLODGEMENT. A FALL WAS REPORTED. LEAD HAD BEEN PULLED AWAY. SHE HAD FALLEN BACKWARD AND BUMPED HER DEVICE. HER URINARY SYMPTOM RETURNED. IT WAS REPORTED THAT IT WAS WORKING GOOD SINCE THEY FIXED IT. THE PATIENT WAS TOLD THEY REINSERTED THAT SAME LEAD. DURING THE REVISION, THERE WERE NO ALLEGATIONS OF SYSTEM USE ISSUE. THE PATIENT RECOVER COMPLETELY. THE CHANGE IN THERAPY/SYMPTOMS WAS SUDDEN. THE REVISION WAS PERFORMED ON (B)(6) 2013 AND THE MANUFACTURER REPRESENTATIVE WAS PRESENT AT THE REVISION. THE NEUROSTIMULATOR WAS FOR GASTROINTESTINAL/ PELVIC FLOOR. 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
    597492 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention