BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3031124 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04481
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 14, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3 889-28, LOT# V822736, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT SAW THEIR MANUFACTURE REPRESENTATIVE AND HAD THEIR DEVICE SETTINGS ADJUSTED. ADDITIONAL INFORMATION RECEIVED ALSO REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AFTER REPROGRAMMING AND NO MALFUNCTIONS WERE NOTICED WITH DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION OF THE LEAD COMPONENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2013. THE PATIENT WAS TO FOLLOW UP WITH THE MANUFACTURER REPRESENTATIVE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135139 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention