BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2030187 · Received March 7, 2011

    Report

    Report Number
    3004209178-2011-01682
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING AN IMPLANT PROCEDURE, HIGH IMPEDANCES (>4000 OHMS) WERE SEEN ON MORE THAN HALF OF THE ELECTRODES. THE NEUROSTIMULATOR WAS PULLED OUT OF THE POCKET, CLEANED, ROTATED, AND RETESTED (AT 1.5, 2.0, 3.0 VOLTS AND 300 PW), BUT HIGH IMPEDANCES WERE STILL SEEN. A NEW NEUROSTIMULATOR WAS THEN USED AND, AFTER RETESTING, HIGH IMPEDANCES WERE STILL SEEN. THE LEAD WAS THEN REPLACED AT WHICH TIME TESTING SHOWED NORMAL IMPEDANCES WERE SEEN AND THE PATIENT HAD BOTH MOTOR AND SENSORY RESPONSES TO THE STIMULATION. THE PATIENT WAS REPORTED AS DOING FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR LEAD: MODEL 3889, LOT# V649846| IMPLANTED:| EXPLANTED: