BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3566625 · Received January 9, 2014

    Report

    Report Number
    3004209178-2014-00446
    Event Type
    Injury
    Date Received
    January 9, 2014
    Report Date
    December 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V850492, IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ANOTHER IMPLANTABLE NEUROSTIMULATOR (INS) 2 DAYS PRIOR TO THE DATE OF THE REPORT. IT WAS STATED THAT THE FIRST IMPLANT NEVER HEALED. THE PATIENT ATTRIBUTED THE PROBLEM WITH BEING DIABETIC AND NOT HAVING A SPLEEN. THE PATIENT SPENT 2 WEEKS IN THE HOSPITAL AND 30 DAYS IN A NURSING HOME BEFORE SHE WAS DISCHARGED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THEY RECEIVED ASSISTANCE FROM THEIR PHYSICIAN AND THE MANUFACTURER¿S R EPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. APPOINTMENTS OF (B)(6) 2013 WERE NOTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17585 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| R