BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4212171 · Received October 29, 2014

    Report

    Report Number
    3007566237-2014-03160
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3889-28, LOT # VA0MMM7V01, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE LEAD, THE TINES DID NOT LINE UP WITH THE MARKINGS ON THE LEAD, CAUSING THE TINES TO PREMATURELY DEPLOY. THE EVENT OCCURRED DURING THE PROCEDURE. THE LEAD WAS NEVER IMPLANTED AND REPLACED WITH ANOTHER PRODUCT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. AT THE TIME OF THE REPORTING, THE PATIENT STATUS WAS NOTED AS "ALIVE - NO INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691601 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR