BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2524129 · Received April 9, 2012

    Report

    Report Number
    3004209178-2012-02225
    Event Type
    Injury
    Date Received
    April 9, 2012
    Report Date
    March 14, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD: MODEL 3093-28, LOT# V855059, IMPLANTED: 2012 (B)(6), EXPLANTED: UNKNOWN; PROGRAMMER: MODEL 3037, SERIAL# (B)(4). NO DEVICE ANALYSIS WAS PERFORMED; THE DEVICE MET RISK-BASED ANALYSIS CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S NEUROSTIMULATOR WAS EXPLANTED. THERE WAS NO PROBLEM WITH THE DEVICE; THE PATIENT SIMPLY HAD AN ALLERGIC REACTION. AFTER THE EXPLANT THE PATIENT WAS DOING WELL AND BEING WATCHED BY HER DOCTOR. THE CAUSE OF THE ALLERGIC REACTION WAS IDIOPATHIC.

    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 00065 YR Required Intervention