BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3327209 · Received September 5, 2013

    Report

    Report Number
    3004209178-2013-15695
    Event Type
    Malfunction
    Date Received
    September 5, 2013
    Report Date
    August 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V952224, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD JUST HAD SURGERY FOR A SCAR REVISION. THE HEALTHCARE PROFESSIONAL (HCP) TRIED TO SYNC THE PATIENT PROGRAMMER WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) AND SAW A CALL YOUR DOCTOR SCREEN. THE HCP WAS UNABLE TO ADJUST STIMULATION. IT WAS NOTED THAT THERE WAS A POWER ON RESET (POR) CONDITION. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442415 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR