BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4132908 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18100
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 8, 2014
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTS WHILE STIMULATION WAS TURNED ON PAIN AND BULGING SENSATION. PATIENT KEEPS THERAPY ON 24/7. THE EVENT OR SYMPTOMS WOULD OCCUR FOLLOWING STRENUOUS ACTIVITY OR EXERCISE. IT WAS NOTED THAT THE PATIENT WAS A HOUSEKEEPER AND HER RESPONSIBILITIES INVOLVES ACTIVITIES THAT WER REPETITIVE IN THE BENDING, TWISTING, STRETCHING AND HEAVY LIFTING. THE ISSUE BECOMES MORE INTENSE AFTER WORKING. THE LOCATION OF THE PATIENT'S SYMPTOMS WAS AT THE PARESTHESIA AREA. THE PATIENT'S STATUS WAS UNDETERMINED AND THE PATIENT WAS AT HOME. PATIENT HAD SEEN HER PHYSICIAN AND WAS TOLD THAT A NERVE COULD BE IRRITATED HOWEVER NO RECOMMENDATIONS FOR PAIN RELIEF WERE PROVIDED. THE PATIENT HAD REQUESTED CT SCAN. AN OPTION WAS REVIEWED WITH THE PATIENT ON TURNING STIMULATION OFF FOR SHORT PERIOD TO DETERMINE IF SENSATION CHANGES WITH STIMULATION OFF. IT WAS REPORTED OVER A MONTH LATER THAT THE HEALTHCARE PROVIDER REPORTS THE EVENT ATTRIBUTED TO THE LEAD. IT WAS NOTED LIKELY NOT FOR EXPLANT. THE PATIENT DIAGNOSIS ASSOCIATED WITH EVENT WAS OAB (OVERACTIVE BLADDER) AND URGE UI (URINARY INCONTINENCE). THE SIGNS AND SYMPTOMS ASSOCIATED WITH THE EVENT WAS OVERSTIMULATION, PAIN AND SENSORY CHANGES. IT WAS NOTED THAT THE PATIENT HAD AN ELECTRONIC STIMULATION THAT WAS PAINFUL TO HER VAGINAL AREA, LIKELY ANOTHER NERVE WAS BEING STIMULATED BY THE NEUROSTIMULATOR. A CT SCAN WAS PERFORMED ON FEBRUARY 09 ON VULVA(ILLEGIBLE) MASS. SHE WAS CONCERNED OVER MASS/CANCER. REPROGRAMMING WAS DONE WITH REPRESENTATIVE ON OCTOBER TO NOVEMBER 2008 AND NO CHANGE NOTED. PATIENT OUTCOME WAS NOTED AS NON-SERIOUS INJURY/ILLNESS. LIKELY WILL HAVE CHRONIC IRRITATION OF THIS NERVE FROM THE NEUROSTIMULATOR. SHE WILL LIVE WITH. IT WAS LATER REPORTED THE PATIENT HAD CT SCAN DONE. HEALTHCARE PROVIDER WAS UNABLE TO TELL IF LEADS/STIMULATOR HAD MOVED/MIGRATED BECAUSE NO CT WAS DONE SHORTLY AFTER IMPLANT SO NO COMPARISON COULD BE DONE. THE PATIENT REPORTS SHE HAS BONE DISEASE IN THE AREA. THE BONE DISEASE COULD BE THE CAUSE OF THE PAIN OR SOME OF THE PAIN. THE PATIENT WAS TAKING ORAL MEDICATION FOR THE BONE DISEASE. WHILE STIMULATION WAS TURNED OFF, THE PATIENT REPORTS SHE TRIED TURNING STIMULATION OFF FOR ABOUT 5 MINUTES AND THE BULGING FEELING WAS STILL PRESENT. THE HEALTHCARE PROVIDER HAD TOLD THE PATIENT BECAUSE HER STIMULATION LEVEL WAS HIGH, SHE WILL CONTINUE TO FEEL BULGING/PAIN. THE PATIENT NOTED IF SHE TURNS STIMULATION DOWN, SYMPTOM CONTROL WASN¿T AS EFFECTIVE. SHE WAS LAST REPROGRAMMED A FEW MONTHS AGO. THE PATIENT WAS WANTING TO KNOW IF ANYTHING CAN BE DONE ABOUT BULGING/PAIN SENSATION. ADDITIONAL INFORMATION REPORTED A FEW YEARS LATER THAT THE PATIENT MENTIONS HAVING THE LEADS AND INS MOVED TO THE OTHER SIDE OF HER BODY 4 YEARS AGO BECAUSE SHE WAS FEELING STIMULATION/ SHOCKING IN HER PRIVATES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER NOTED THAT THERE WAS POOR LEAD PLACEMENT IN 2010 WHICH WAS LEAD REVISION DATE. SEE ALSO MANUFACTURER'S REPORT # 3004209178-2014-18064.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613272 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention