BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2803241 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09486
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    September 26, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V758211, IMPLANTED: 2011 (B)(6), 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'S DEVICE DID NOT WORK FROM THE BEGINNING, AND THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT EXPERIENCED PAIN ON THE LEFT SIDE OF HER HIP, BUT IT WAS NOTED THAT THE IMPLANT IS ON THE RIGHT SIDE. THE PAIN WAS PRESENT WHEN THE INS IS ON AND OFF. IT WAS ALSO REPORTED THAT THE PATIENT WAS REPROGRAMMED ON (B)(6) 2012 AND THE PAIN BEGAN SHORTLY AFTERWARDS, THOUGH IT WAS LATER REPORTED THAT THE PAIN HAD BEEN PRESENT SINCE DAY ONE. IT WAS NOTED THAT THE PATIENT ALSO HAD APPOINTMENTS ON (B)(6) 2012 AND (B)(6) 2012. THE PATIENT MET WITH HER HCP ON (B)(6) 2012 AND WAS TOLD THE DEVICE WAS NOT WORKING. AN APPOINTMENT WAS SCHEDULED FOR (B)(6) 2012 TO REMOVE THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE 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