BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4110882 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17548
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 29, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# VA05NGV, IMPLANTED: 2013 (B)(6); 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 A PATIENT HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD WERE REMOVED, BUT A PORTION OF THE LEAD WAS LEFT INTERNALIZED. THE REPORTER THOUGHT THAT ONE ELECTRODE WAS LEFT IN THE PATIENT BASED ON AN X-RAY AND THEY WERE TRYING TO CLEAR THE PATIENT FOR A LUMBAR MRI. THE REASON FOR THE MRI WAS UNRELATED BACK SURGERY. IT WAS THOUGHT THAT THE SYSTEM WAS REMOVED IN ORDER TO DO AN MRI BUT THE REPORTER WAS UNSURE. AT THIS TIME THERE WOULD NOT BE A LUMBAR MRI DONE DUE TO THE RISK TO THE PATIENT. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591795 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other