BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2961954 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02652
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 29, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V700596, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY REPORTED CONCLUSION CODES NO LONGER APPLY TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEAD HAD MIGRATED. THE LEAD WAS EXPLANTED FROM THE LEFT SIDE AND WAS REPLACED WITH A NEW LEAD ON THE RIGHT SIDE. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD A PREMATURELY LOW BATTERY, WHICH WAS ALSO REPLACED DURING THE PROCEDURE. IT WAS POST-OPERATIVELY NOTED THAT THE PATIENT HAD UTILIZED AN "AMPLITUDE UP TO 8.5" WITH THEIR PREVIOUS DEVICE. IN RECOVERY, THE PATIENT REPORTED SENSATION ON ALL FOUR STANDARD PROGRAMS WITH "SENSATION IN HER VAGINA." IF FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65079 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention