BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2798988 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-09359
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    September 24, 2012
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V813487, IMPLANTED: (B)(6) 2011, 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 THE PATIENT HAD A SHOCKING/JOLTING SENSATION IN HIS STOMACH AND HIS KNEES. THE PATIENT HAD IMPLANTED ON (B)(6) 2012, AND THE PATIENT STATED THE STIMULATION WAS IN WRONG LOCATION AND THAT IT SHOULD BE IN FOOT. THE THERAPY WAS IMPLANTED TO HELP WITH THE PATIENT'S PAIN IN HIS LEGS. THE PATIENT'S TRAIL WORKED PERFECTLY. THE PATIENT TRIED TO SWITCH GROUPS APPEARED HE ONLY HAD ONE. THE PATIENT HAD COMPLICATIONS AFTER SURGERY WHICH WAS HIS PAIN MEDICATION. THE PATIENT HAD TO STAY LONGER DUE TO SOME COMPLICATIONS. THE PATIENT DIDN'T THINK THE COMPLICATIONS WERE DEVICE RELATED. THE PATIENT BELIEVED THEY WERE RELATED TO MEDICATIONS. IT WAS UNKNOWN WHEN THE SYMPTOMS BEGAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention