BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2524063 · Received April 9, 2012

    Report

    Report Number
    3004209178-2012-02222
    Event Type
    Malfunction
    Date Received
    April 9, 2012
    Report Date
    March 29, 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
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL # 3889-28, LOT # V813487, IMPLANTED: (B)(6) 2011, EXPLANTED UNKNOWN; PROGRAMMER MODEL # 3037, LOT # NJD138348N. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT WITH NO STIMULATION SENSATION. THE EVENT OR SYMPTOMS OCCURRED FOLLOWING A FALL THAT OCCURRED A FEW DAYS AGO. THE PATIENT HAD AN APPOINTMENT WITH THEIR HEALTHCARE PROVIDER. IT WAS CONFIRMED THAT THE INS WAS ON. PATIENT WAS ON PROGRAM 3 AT 3.7. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    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