BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3463197 · Received November 12, 2013

    Report

    Report Number
    3004209178-2013-20623
    Event Type
    Injury
    Date Received
    November 12, 2013
    Report Date
    October 18, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # V881399, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ABOUT A MONTH PRIOR TO THE DATE OF THIS REPORT, IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD NOTICED A RETURN OF LEAKAGE. IT WAS ADDITIONALLY NOTED THAT THE PATIENT WOULD ITCH NEAR THEIR SCAR ONCE IN A WHILE. IT WAS STATED THE PATIENT WAS UNABLE TO MAKE ADJUSTMENTS USING THE PROGRAMMER WITH OR WITHOUT THE ANTENNA ATTACHED. IT WAS NOTED THAT THE PROGRAMMER WOULD NOT DO TELEMETRY. THE COMPLAINT ABOUT THE PROGRAMMER WAS NOT VERIFIED BY ANALYSIS. ON THE DATE OF THIS REPORT, IT WAS INDICATED THE IMPLANTABLE NEUROSTIMULATOR WAS REPLACED ON (B)(6) 2013. THE PROGRAMMER WAS ALSO RES ET FOLLOWING THE SURGERY. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581020 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention