BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2800493 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-09423
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD; (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PAIN IN PELVIS WHEN STIMULATION WAS ON. AN IMPEDANCE CHECK FOUND HIGH IMPEDANCES OVER 4,000 OHMS ON ALL CHANNELS AND PROGRAMS. THE PATIENT FELT PAIN EVEN WITH STIMULATION ON 0 VOLTS. THE STIMULATION WAS TURNED OFF. AN X-RAY WAS SCHEDULED FOR THREE DAYS LATER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE POSITION OF THE IMPLANTABLE NEUROSTIMULATOR WAS CHANGED AND THE PATIENT WAS "FINE WITH THAT." THE REPORTER STATED THAT THE LEAD WAS RECONNECTED TO THE IMPLANTABLE NEUROSTIMULATOR AND IT WAS UNKNOWN IF THERE WERE IMPEDANCE ISSUES. IT WAS NOTED THAT THE PATIENT HADN'T CONTACTED THE CLINIC IN TWO MONTHS. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A SHOCKING OR JOLTING SENSATION, AND IT WAS UNCLEAR WHEN THE SENSATION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention