BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6109841 · Received November 17, 2016

    Report

    Report Number
    3004209178-2016-24252
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 30, 2016
    Report Date
    November 17, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V161679, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID 3889-28, LOT# V161679, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT NEED AN MRI FOR LOSS OF FUNCTION IN ALL EXTREMITIES. IT WAS REPORTED THAT THE INS AND TWO LEADS WERE EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP AND IT WAS REPORTED THAT THE RESULTS OF THE MRI WERE UNKNOWN AND ACTIONS/INTERVENTIONS WERE ALSO UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759359 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention