BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4161861 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19420
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3889-28, LOT# VA0KHG5, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THE CALLER CALLED ABOUT ANOTHER PATIENT AND THEN REFERENCED THAT THIS PATIENT HAD SIMILAR ISSUES WITH SENSITIVITY TO SETTINGS. CALLER STATES THIS PATIENT HAS IC (INTERSTITIAL CYSTITIS) AND WAS CALLING HER NON-STOP. CALLER STATES THAT SHE HELPED HER SO MUCH AND THEY WERE CONSTANTLY ADJUSTING STIMULATION AND READJUSTING SETTINGS FOR COMFORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND RETURN OF SYMPTOMS OVER THE PAST FOUR DAYS. THE DAY OF THE REPORT, THE PATIENT USED HER PATIENT PROGRAMMER IN INCREASE STIMULATION, AND ONCE IT WAS CONNECTED, IT SHOWED THAT THE DEVICE WAS SET AT 0.0 VOLTS ON PROGRAM 1, WHICH EXPLAINED WHY THE SYMPTOMS RETURNED. THE PATIENT SAID THAT SOMETHING TURNED STIMULATION DOWN, AS A WEEK PRIOR SHE HAD ADJUSTED STIMULATION TO 1.4 OR 1.5 VOLTS. SHE DIDN¿T KNOW IF SHE WAS ON PROGRAM 1 AT THAT TIME. ONCE SHE SAW IT WAS AT 0.0 VOLTS, THE PATIENT INCREASED STIMULATION. WHEN SHE GOT TO 0.9 VOLTS, SHE IMMEDIATELY JUMPED AND FELT A REALLY SHARP PAIN IN HER LOWER BACK AT THE BASE OF HER BACK AND THE TOP OF HER BUTT CRACK. SHE STOPPED INCREASING STIMULATION, THEN A COUPLE OF MINUTES LATER SHE DID IT AGAIN. SHE COULD GO UP TO 1.8-2.0 VOLTS AND WASN¿T FEELING STIMULATION ANYWHERE LIKE BEFORE. SHE USED TO FEEL STIMULATION IN THE VAGINAL AREA AND NOW SHE FELT IT AT THE TOP OF HER BUTT CRACK. STIMULATION WAS IN THE WRONG LOCATION AND THE PATIENT WAS CONCERNED NOW THAT SHE FELT IT IN A COMPLETELY DIFFERENT AREA. THE PATIENT HAD NOT HAD ANY MEDICAL PROCEDURES DONE LATELY AND HADN¿T HAD ANY FALLS OR INJURIES, BUT HAD BEEN WORKING OUT. THE PATIENT CALLED HER HEALTHCARE PROVIDER AND WAS WAITING FOR A CALL BACK. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REPRESENTATIVE MET WITH THE PATIENT ON (B)(4). THE REPRESENTATIVE DID SOME REPROGRAMMING, ADJUSTED PULSE WIDTH RATE AND THAT'S WHAT THEY DID JUST FOR COMFORT SETTINGS. IT WAS LATER REPORTED THAT AT THE (B)(6) 2014 APPOINTMENT THE PATIENT ONLY SAID SHE WOULD GET AN UNCOMFORTABLE SENSATION IN HER VAGINAL AREA SOMETIME. SHE DID NOT USE THE WORD "ZAPPING" IN THE REPRESENTATIVE PRESENCE. THE REPRESENTATIVE HAD NO INFORMATION ABOUT THE DEVICE TURNING OFF ON ITS OWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THERE WAS A FIFTY PERCENT OR GREATER SYMPTOM REDUCTION. THE PATIENT COMPLAINT OF TWITCHING OF HER FOOT AT 1.7 WHEN SHE DECREASES SETTING THE SYMPTOMS RETURN. ALSO COMPLAINT OF ¿ZAPPING¿ SENSATION IN BUTTOCKS AND THE NEUROSTIMULATOR SHUT ITSELF OFF RANDOMLY. THE MANUFACTURER REPRESENTATIVE WAS NOTIFIED AND MET WITH THE PATIENT IN THE OFFICE AND REPROGRAMMED NEUROSTIMULATOR ON (B)(6) 2014. INITIALLY THE PATIENT WAS COMFORTABLE WITH THE NEW SETTING BUT ¿ZAPPING¿ RETURNED ALONG WITH INCREASED PAIN AND IC (INTERSTITIAL CYSTITIS )SYMPTOMS. THE REPORTED APPOINTMENT WERE (B)(6) 2014 AND (B)(6) 2014. THE PATIENT NOT RECOVERED AND SYMPTOMS ISSUE WAS ONGOING. THE PATIENT APPOINTMENT WITH THE HEALTHCARE PROVIDER WAS ON (B)(6) 2014 TO DISCUSS POSSIBLE REMOVAL OF NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639637 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR