BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2805180 · Received October 25, 2012

    Report

    Report Number
    3004209178-2012-09571
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    September 28, 2012
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_PROG, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 3889-28, LOT# V952323, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THIS OCCURRED AFTER THE PATIENT HAD A CT SCAN PERFORMED THE WEEK PRIOR TO THE REPORT. IT WAS FURTHER NOTED THAT THE PATIENT FELT AN INCREASE IN 'URINARY SIDE EFFECTS.' IT WAS NOTED THAT THE PATIENT DID NOT HAVE HER PATIENT PROGRAMMER, SO SHE WAS UNABLE TO CHECK THE STATUS OF HER DEVICE. THE PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS 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