BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2744093 · Received September 13, 2012

    Report

    Report Number
    3004209178-2012-08103
    Event Type
    Malfunction
    Date Received
    September 13, 2012
    Report Date
    August 16, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT#: V913913, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT'S STIMULATION WAS TURNED ON, SHE FELT PAIN AT HER IMPLANTABLE NEUROSTIMULATOR (INS) SITE. THE PAIN WENT AWAY WITHIN 1 - 2 DAYS AFTER THE INS WAS TURNED OFF. THE PATIENT TRIED MULTIPLE PROGRAMS BUT HER SYMPTOMS WERE NOT RESOLVED. NO SIGNS OF INFECTION WERE DETECTED. IT WAS UNKNOWN IF PALPATING CAUSED STIMULATION CHANGES, BUT IT WAS NOTED THAT IT DID CAUSE PAIN WITHIN 2 INCHES OF THE IMPLANT SITE; IT WAS NOTED THAT PAIN OCCURRED WITH THE INS ON AND OFF. HIGH IMPEDANCES, GREATER THAN 4,000 OHMS, WERE MEASURED ON ELECTRODE BIPOLAR PAIRS #0/2, 0/3, AND 2/3; IT WAS NOTED THAT THE PATIENT GOT THE BEST THERAPEUTIC BENEFIT FROM ONE OF THESE PAIRS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED REPORTED, THE PATIENT'S SORENESS IN THE DEVICE POCKET AREA WHEN STIMULATION WAS ON BUT WOULD GO AWAY AFTER ABOUT 12 HOURS IF STIMULATION WAS TURNED OFF. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS, BUT IT HAD BEEN HAPPENING SINCE IMPLANT. THE PATIENT WAS RUNNING STIMULATION AT ABOUT 1.0-1.5V AND IF STIMULATION WAS HIGHER, PATIENT FELT STIMULATION IN VAGINAL AREA AND DOWN LEG, BUT ONCE STIMULATION IN NORMAL VALUE THAT SENSATION WENT AWAY. IT WAS ALSO REPORTED THAT DUE TO THE HIGH IMPEDANCE ISSUE, A NURSE WAS ABLE TO PROGRAM AROUND THOSE ELECTRODE PAIRS (0/1, 0/2, AND 0/3 WERE GREATER THAN 4000 OHMS), BUT THE PATIENT WAS STILL HAVING ISSUE WITH "SORENESS." ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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