BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3100411 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-07388
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 10, 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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE DEVICE, SERIAL #(B)(4), FOUND NO ANOMALY. ANALYSIS OF THE LEAD, LOT #V122742, FOUND NO SIGNIFICANT ANOMALY. THE LEAD BODY AND CONDUCTORS WERE BROKEN DUE TO OVERSTRESS AND DAMAGE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-33, LOT# V122742, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DISLODGMENT; THE LEAD HAD MIGRATED TO JUST UNDER THE SURFACE OF THE SKIN TO WHERE IT WAS VISIBLY PROTRUDING. THE LEAD HAD NOT BROKEN THE SURFACE OF THE SKIN. THE HEALTHCARE PROVIDER REMOVED THE OLD LEAD AND BATTERY AND IMPLANTED A NEW LEAD AND BATTERY. THE PATIENT WAS CURRENTLY HAVING SUCCESSFUL STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201659 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention