BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2832251 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10269
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 17, 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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3889-28 LOT# V800628, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3889-28 LOT# V842736, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF THERAPEUTIC EFFECT FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AS THEY HAD TO CATHETERIZE THEMSELVES MORE. IT WAS NOTED THAT THE PATIENT FELT THE INS ON THE RIGHT SIDE (PATIENT HAD 2 INS SYSTEMS) HAD COME OUT OF THE POCKET AROUND (B)(6) 2012. THE PATIENT STATED THAT IT WAS A LITTLE PAINFUL AND ANNOYING. THE PATIENT ALSO MENTIONED THAT THE SAME INS ON THE LEFT SIDE HAD COME OUT OF ITS POCKET ABOUT A MONTH TO TWO MONTHS AGO AND THAT THEIR PHYSICIAN PUSHED IT BACK INTO PLACE. THE PATIENT REPORTED THEY WERE UNABLE TO PUSH THE RIGHT INS BACK INTO THE POCKET. THE PATIENT ALSO REPORTED ACTIVITIES OF BEING ON THE "DRILL TEAM" AND HAD BEEN HELPING HER HUSBAND AFTER HIS KNEE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. SEE ALSO MANUFACTURER'S REPORT # 3004209178-2012-10268

    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