BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4148371 · Received October 7, 2014

    Report

    Report Number
    3004209178-2014-18432
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    August 31, 2012
    Report Date
    September 15, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V813549, IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-28, LOT# V813549, IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    CORRECTION: THE RIGHT LEAD WAS REVISED ON 2013-(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S RIGHT IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED FIRST. IN 2013, THE LEFT INS WAS IMPLANTED AND THEY REVISED THE RIGHT LEAD. THE RIGHT LEAD WAS REVISED ON 2014 (B)(6). NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627294 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention