BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3092467 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07274
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 29, 2013
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-33, LOT# VA0477X, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIDN'T HAVE PAIN RIGHT AFTER SHE WAS IMPLANTED. HOWEVER, AS OF THE LAST 6 MONTHS, THE PATIENT HAD "UNBEARABLE PAIN" IN THE TAILBONE AND RECTUM AREA THAT HAD LASTED FOR THE LAST 6 WEEKS. THE REPORTER STATED THAT THE PATIENT BROKE HER TAILBONE A YEAR PRIOR TO THE REPORT. THE PATIENT BELIEVED THAT THE PAIN WAS RELATED TO THE IMPLANT BECAUSE SHE NEVER HAD "PAIN LIKE THIS" UNTIL SHE WAS IMPLANTED. IT WAS NOTED THAT THE PATIENT USED AMPLITUDES FROM 1.1V TO 1.7V AND WAS GETTING "GREAT" SYMPTOM CONTROL. THE REPORTER INDICATED THAT THE PATIENT WAS SCHEDULED TO MEET HER HEALTHCARE PROVIDER (HCP) ON (B)(6) 2013. IT WAS LATER REPORTED THAT THE PATIENT'S HCP SWITCHED THE PATIENT'S PROGRAM ON (B)(6) 2013. HOWEVER, THE PATIENT CONTINUED TO FEEL PAIN EVEN AFTER DECREASING AMPLITUDE TO 1.0V. WHEN THE PATIENT DECREASED STIMULATION TO 0.4V, IT "STILL DIDN'T FEEL RIGHT". AT THE TIME OF THE REPORT, THE PATIENT'S PROGRAM WAS SWITCHED AND REPORTEDLY FELT "MUCH BETTER". THE PATIENT COULD FEEL STIMULATION IN THE VAGINAL AREA. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT HAD RECEIVED ASSISTANCE FROM THEIR PHYSICIAN OR THE MANUFACTURER'S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. THE PATIENT WENT FROM PROGRAM 1.7 TO 3.4. THE PATIENT WAS HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR PHYSICIAN OR THE MANUFACTURER'S REPRESENTATIVE. IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT HADN'T SLEPT IN 48 HOURS AND THAT SHE HAS BEEN IN PAIN ALL WEEKEND. THE PATIENT'S BLOOD PRESSURE HAD GONE UP THIS WEEKEND AND SHE WAS HEARING ECHOING IN HER HEAD - THE PATIENT WAS HEARING HER GARAGE DOOR OPEN WHEN IT SHOULDN'T. THE PATIENT WAS SHAKY AND NERVOUS. IF THE PATIENT TURNS DEVICE UP HER BLOOD PRESSURE GOES UP AND SHE GETS ECHOING IN HER EARS. THE PATIENT WAS TRYING TO MAKE ADJUSTMENTS TO HER DEVICE ALL WEEKEND AND NOTED THAT WHEN IT WAS ON SHE WOULD FEEL PAIN IN ONE OF THREE LOCATIONS - CENTER OF CROTCH, IN THE RECTUM AND TO THE RIGHT OF CROTCH. THE PATIENT WAS CURRENTLY ON PROGRAM 3 AT .2V. THE PATIENT NEEDED REEDUCATION ABOUT WHAT/HOW PROGRAMS ARE. THE PATIENT TRIED TURNING HER DEVICE OFF LAST NIGHT AND THEN GOT PAIN IN HER SHOULDER BLADE AND NECK AREA SO SHE TURNED DEVICE BACK ON. THE PATIENT PLANNED TO SEE HEALTHCARE PROVIDERS. IT WAS ALSO NOTED THAT THE PATIENT BROKE HER TAILBONE IN THE PAST AND HAD TWO STENTS IN HER HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193817 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Other