BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2190802 · Received July 28, 2011

    Report

    Report Number
    3004209178-2011-05861
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IRREGULAR IMPEDANCES WERE ALSO MEASURED. THE NEUROSTIMULATOR AND LEAD WERE EXPLANTED AND REPLACED. IT WAS NOTED THAT DURING EXPLANT THERE WAS SOME DIFFICULTY REMOVING THE LEAD FROM THE NEUROSTIMULATOR AND THE LEAD BROKE WHILE ATTEMPTING TO REMOVE IT. THE PATIENT INCURRED NO INJURY AND RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD086880N| LEAD: MODEL 3093, LOT# V267751