BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3853548 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10247
    Event Type
    Injury
    Date Received
    June 6, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 093-28 LOT# V955825, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD AN INFECTION IN THEIR COLON A MONTH OR TWO PRIOR TO CALL.

    Description of Event or Problem · 1

    INFORMATION RECEIVED LATER INDICATED THAT PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THE HEALTHCARE PROVIDER. THE PATIENT APPOINTMENT WAS SCHEDULED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331290 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention