BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2501274 · Received March 23, 2012

    Report

    Report Number
    3004209178-2012-01791
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Report Date
    February 28, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): LEAD MODEL 3889-28, LOT# V251860, IMPLANTED: (B)(6)-2009, EXPLANTED: NA, PROGRAMMER MODEL 3037, SERIAL# (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HIS HCP OR A MANUFACTURER REPRESENTATIVE AND HIS CONCERNS WERE RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING DEFIBRILLATION THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT RECEIVED A 'CALL YOUR DOCTOR' ICON ON THEIR PROGRAMMER, WITH A POWER ON RESET (POR) CONDITION. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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