BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2842883 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10674
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 26, 2011
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V616902, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4). ANALYSIS OF THE DEVICE, MODEL # 3058, SERIAL # (B)(4), FOUND NO SIGNIFICANT ANOMALY. ANALYSIS OF THE LEAD, MODEL # 3889-28, FOUND THAT THE LEAD WAS STRETCHED. NO SIGNIFICANT ANOMALY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LEG PAIN. IT WAS STATED THAT THE PATIENT "COULD HARDLY LIFT HER LEGS TO WALK." IT WAS NOTED THAT THE DEVICE AMPLITUDE WAS SET AT 6.5 VOLTS. IT WAS STATED THAT AFTER DECREASING TO 0.0 VOLTS AND SLOWLY INCREASING TO 0.9 VOLTS, THE PATIENT WAS "COMFORTABLE" AND THE LEG PAIN AND MOBILITY PROBLEMS WERE GONE. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED A 50% REDUCTION IN URINARY SYMPTOMS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE DELIVERED "INEFFECTIVE PAIN RELIEF" AND THE PATIENT REQUESTED REMOVAL. THE PREVIOUS STATEMENT CONFLICTED WITH DEVICE TYPE. THE REPORTER STATED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.

    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