BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3584531 · Received January 21, 2014

    Report

    Report Number
    3004209178-2014-00845
    Event Type
    Injury
    Date Received
    January 21, 2014
    Report Date
    December 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V062829, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BEGAN HAVING BAD HEADACHES STARTING SEVERAL MONTHS AGO. THE PATIENT HAD HAD BRAIN SCANS TO POTENTIALLY DIAGNOSE THE ISSUE. THE PATIENT WAS TOLD SHE MAY BE HAVING SEIZURES. COMPATIBILITY GUIDELINES WERE REQUESTED FOR THE FOLLOWING: MRI. THE AREA TO BE SCANNED WAS THE HEAD / BRAIN. THE PATIENT WAS NOT SURE IF RELATED TO IMPLANT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46611 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Other