BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3904436 · Received July 1, 2014

    Report

    Report Number
    3004209178-2014-12312
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    June 24, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V913870, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THE PATIENT HAD A LOSS OF BLADDER CONTROL. IT WAS REPORTED THE PATIENT¿S IMPLANT WAS NOT WORKING LIKE IT DID BEFORE. IT WAS NOTED THE STIMULATION WAS BETTER AFTER REPROGRAMMING, BUT IT WAS NO LONGER WORKING. IT WAS REPORTED THE PATIENT DID NOT FEEL STIMULATION, BUT DID BEFORE. IT WAS NOTED THE PATIENT EXPERIENCED FREQUENCY. IT WAS REPORTED THAT THE PATIENT¿S STIMULATION WAS ON. IT WAS NOTED THE PATIENT WAS ABLE TO INCREASE STIMULATION TO A COMFORTABLE LEVEL. IT WAS REPORTED THE PATIENT DID NOT FEEL STIMULATION AS STRONG AS WHEN THEY WERE FIRST IMPLANTED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S URINE WAS CLEAR. IT WAS NOTED THE PATIENT EXPERIENCED NOCTURIA THREE OR FOUR TIMES. IT WAS REPORTED THE PATIENT HAD MORE URGENCY THAN BEFORE. IT WAS NOTED THE PATIENT DID NOT EXPERIENCE DYSURIA, HEMATURIA, OR CALCULI. IT WAS REPORTED THE PATIENT EXPERIENCED HESITANCY. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT FELT STIMULATION ¿HERE AND THERE.¿ IT WAS NOTED THE PATIENT HAD DIFFICULTY CONNECTING THE NEW PROGRAMMER BY THEMSELVES. IT WAS REPORTED THE PATIENT WAS ABLE TO HAVE A FRIEND CONNECT FOR THEM. IT WAS NOTED THE PATIENT WAS ABLE TO INCREASE STIMULATION TO A COMFORTABLE LEVEL ONCE AGAIN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT CALLED THEIR HEALTH CARE PROVIDER (HCP) AND STATED THAT THEY DID NOT THINK THEIR IMPLANT WAS WORKING THE WAY IT SHOULD. THE HCP CALLED THE MANUFACTURER REPRESENTATIVE AND THEY WERE GOING TO CALL THE PATIENT AND LET THE HCP KNOW IF THEY NEEDED TO MAKE AN APPOINTMENT FOR THE MANUFACTURER REPRESENTATIVE TO MEET WITH THE PATIENT. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE TALKED TO THE PATIENT AND THERE WAS NOTHING THEY COULD DO FOR THEM AT THE TIME. THE PATIENT HAD AN APPOINTMENT WITH THEIR HCP ON (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HCP SAW THE PATIENT ON (B)(6) 2014 AND THEY WERE TOLD THAT THE PATIENT HAD 2 RECENT URINARY TRACT INFECTIONS (UTIS) TREATED WITH CIPRO BY THEIR FAMILY HCP. THE PATIENT WAS NOW COMPLAINING OF RECTAL PAIN AND WANTED TO COME IN AND SEE THE HCP. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF THE THERAPY AND THE PATIENT THOUGHT IT WAS NOT WORKING SATISFACTORILY. THE HCP TOLD THE PATIENT WHAT THEY WOULD LIKE TO DO WAS TO GET THEIR URINE CLEARED UP AND THEN THEY WOULD GET THE MANUFACTURER REPRESENTATIVE IN AND SEE IF THEY COULD HELP ADJUST IT TO HELP THEM BECAUSE THE PATIENT WAS DOING WELL ON THE THERAPY PREVIOUSLY. IT WAS REPORTED THAT THE PATIENT¿S ABDOMEN WAS SOFT AND THERE WERE NO PALPABLE MASSES, ORGANOMEGALY OR SIGNIFICANT TENDERNESS. ON THE PELVIC EXAM THE PATIENT HAD AN OBVIOUS CANDIDA INFECTION OF THE LABIA BILATERALLY AND THE VAGINAL WALL WAS STENOTIC BUT NO VAGINAL LESIONS WERE VISUALIZED. IT WAS NOTED THAT ON THE RECTAL EXAM THE PATIENT HAD SOME INCLUSION CYSTS AT ABOUT THE 10 O¿CLOCK POSITION BUT THE RECTAL EXAM WAS OTHERWISE UNREMARKABLE. THE PLAN WAS TO PUT THE PATIENT ON SOME BACTRIM PENDING A URINE CULTURE AND SENSITIVITY AND MYCOLOG FOR THE PATIENT¿S CANDIDA INFECTION AND THEY WOULD CHECK ON THE PATIENT IN 2 WEEKS¿ TIME. IT WAS REPORTED THAT THE HCP SAW THE PATIENT ON (B)(6) 2014 AND THE PATIENT CAME IN AND WAS SO DISAPPOINTED SINCE THEY PUT THE DEVICE IN (B)(6) 2012 THEY HAD JUST BEEN PERFECT AND DIDN¿T HAVE TO WEAR A PAD. THE PATIENT COULD GO 6 HOURS IN BETWEEN VOIDING AND LATELY NOW THEY HAD BEEN BACK TO HAVING FREQUENCY, URGENCY, AND INCONTINENCE. IT WAS NOTED THAT THE PATIENT HAD BEEN TAKING VESICARE AND THEIR URINALYSIS SHOWED AN OBVIOUS UTI. THE HCP WAS GOING TO PUT THE PATIENT ON CIPRO THEN PENDING A URINE CULTURE AND SENSITIVITY AND HAD REFILLED THE VESICARE AND WOULD RECHECK THE PATIENT IN THE OFFICE IN 2 WEEKS¿ TIME. TWO WEEKS LATER ON (B)(6) 2014, THE PATIENT¿S URINE WAS NOW CLEAR AND THE HCP WAS GOING TO TRY TO GET THE MANUFACTURER REPRESENTATIVE IN AND SEE IF THERE WAS A WAY TO READJUST THE DEVICE. IT WAS STATED THAT THE PATIENT WAS ALSO SEEN ON (B)(6) 2013 POST-IMPLANT AND THE PATIENT WAS TAKING SUPPLEMENTAL VESICARE. THE PATIENT HAD FELT A DRAMATIC IMPROVEMENT BUT STILL HAD NOCTURIA 2 TIMES. IT WAS REPORTED THAT THE PATIENT COULD GO GREATER THAN 3 HOURS DURING THE DAYTIME BUT HAD SOME URGENCY AND URGENCY INCONTINENCE AND THEY QUIZZED THE PATIENT ABOUT THE COMPLICATIONS THEY WERE GETTING FROM VESICARE AND THE PATIENT WAS NOT BOTHERED AT ALL WITH CONSTIPATION OR EXCESSIVE DRY MOUTH. THEY WOULD INCREASE THE VESICARE AND SEE HOW THE PATIENT DID. IT WAS NOTED THAT THE HCP WENT OVER THE REVIEW OF SYSTEMS FORM AND IT WAS NONCONTRIBUTORY AND THE PLAN WAS TO HAVE THE PATIENT CALL IN 2 WEEKS¿ TIME WITH THEIR RESULTS AND THEN CHECK ON THEM IN 6 MONTHS¿ TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383953 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention