INTERSTIM II
Report
- Report Number
- 3004209178-2013-11954
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Report Date
- July 12, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P080025
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER; PATIENT PRODUCT ID 3889-28, LOT# VA01R12, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER; PATIENT PRODUCT ID 3037,SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).
(B)(4).
IT WAS REPORTED THAT THE PATIENT SAW THE STIMULATOR WITH A QUESTION MARK AND IT LOOKED LIKE AN APPLE BESIDE IT ON THE PROGRAMMER SCREEN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A SCREEN ON THEIR PROGRAMMER WITH A BATTERY POINTING TO TWO BOXES WITH A TRIANGLE ON TOP. THE PROGRAMMER WAS NOT CONNECTING WITH THE IMPLANT. IT WAS REPORTED THAT CHANGING THE BATTERIES RESOLVED THE COMMUNICATION ISSUE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A BLANK SCREEN ON THEIR PROGRAMMER. THE PATIENT REPLACED THE BATTERIES AND THEN THE PROGRAMMER WORKED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING INCONTINENCE AND CONSTIPATION. THE PATIENT REPORTED THAT SHE HAD TAKEN MEDICATION FOR INCONTINENCE AND CONSTIPATION HER ENTIRE LIFE, BUT OVER THE LAST "MONTH OR TWO" IT HAD NOT HELPED THE ISSUE. THE PATIENT WANTED TO CHANGE PROGRAMS. THE PATIENT HAD THOUGHT SHE WAS ON PROGRAM 3 AND WANTED TO CHANGE TO PROGRAM 4, BUT UPON INTERROGATION IT WAS FOUND THAT THE PATIENT WAS ON PROGRAM 2 AT AN AMPLITUDE OF 1.0V. THE PATIENT THEN CHANGED TO PROGRAM 3 AND INCREASED STIMULATION TO 1.1V. THE PATIENT STATED THAT WAS FEELING STIMULATION AND WANTED TO TRY THIS SETTING. LATER THAT DAY IT WAS REPORTED THAT THE PATIENT WANTED TO TURN STIMULATION DOWN BECAUSE IT FELT "TOO STRONG LIKE A LOT OF SHOCKS" AND FELT LIKE SHE WAS "BEING ELECTROCUTED." THE PATIENT ADJUSTED STIMULATION DOWN FROM 1.1V TO 0.9V AND STATED THAT IT FELT BETTER. IT WAS NOTED THAT THE PATIENT WAS STANDING WHILE TURNING STIMULATION DOWN AND AFTER SITTING DOWN SHE DID NOT FEEL ANYTHING. IT WAS VERIFIED THAT STIMULATION WAS ON. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
THE PATIENT STATED THAT THE DEVICE HAD HELPED HER BOWEL INCONTINENCE AND DAYTIME URINARY INCONTINENCE. THE PATIENT USED TO HAVE URINARY FREQUENCY AND RAN TO THE BATHROOM OFTEN BUT AT THE TIME OF THE REPORT SHE WAS ABLE TO "GET TO THE TOILET" DURING THE DAY. HOWEVER, THE DEVICE HAD NOT HELPED WITH URINARY INCONTINENCE "AT ALL AT NIGHT." THE PATIENT ALSO BELIEVED SHE NEEDED TO TURN HER STIMULATION DOWN BECAUSE "THE WEEK PRIOR TO THE REPORT" SHE HAD PAIN GOING DOWN HER RIGHT THIGH. THE PATIENT ALSO HAD "SORENESS, IT WAS VERY SORE" BETWEEN HER BUTTOCKS AND VAGINAL AREA WHICH BEGAN "ABOUT A WEEK" PRIOR TO THE REPORT. THE PATIENT STATED THAT SHE TOOK "MIRALAX AND CONSULT ONCE A DAY" FOR HER CONSTIPATION WHICH HAD WORKED FOR HER IN THE PAST BUT AT THE TIME OF THE REPORT SHE HAD NOT HAD A BOWEL MOVEMENT "AT ALL" FOR "ABOUT FOUR TO FIVE DAYS." THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMAS SINCE IMPLANT. THE PATIENT WAS ASSISTED IN ADJUSTING HER STIMULATION FROM 0.7 TO 0.6 AND THEN BACK TO 0.7 VOLTS. THE PATIENT WANTED TO DECREASE STIMULATION DUE TO THE OVERSTIMULATION, BUT WAS UNABLE TO FEEL IT AT 0.6 VOLTS. THE PATIENT THEN SWITCHED TO PROGRAM 2 AT 0.7 VOLTS FROM PROGRAM 1 AND FELT STIMULATION COMFORTABLY IN THE BICYCLE SEAT AREA. EIGHT DAYS LATER THE PATIENT REPORTED THAT SHE HAD HAD NO HELP WITH BLADDER INCONTINENCE SINCE IMPLANT. THIS WAS UNCLEAR BECAUSE THE PATIENT PREVIOUSLY REPORTED BLADDER CONTROL DURING THE DAY BUT NOT AT NIGHT. THE DEVICE HAD HELPED WITH FECAL INCONTINENCE BUT THE PATIENT HAD BECOME "SEVERELY" CONSTIPATED. THE PATIENT WAS ALSO UNABLE TO FEEL STIMULATION BUT WAS ASSISTED IN ADJUSTING IT. THE PATIENT WENT FROM PROGRAM 2 AT 0.7 VOLTS TO 0.8 VOLTS. IT WAS "A LITTLE TOO STRONG" AT FIRST BUT "LEVELED OUT" SINCE SHE STARTED TO "WALK AROUND A BIT." THE PATIENT STATED STIMULATION WAS COMFORTABLE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HER DEVICE OR THERAPY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WORKED FOR THE PATIENT'S FECAL INCONTINENCE BUT NOT BLADDER INCONTINENCE. THE PATIENT WAS IMPLANTED FOR FECAL INCONTINENCE, BUT THE PATIENT'S DOCTOR INDICATED THAT SOMETIMES IT HELPED WITH THE BLADDER, BUT SHOULD NOT EXPECT IT. IT WAS NOTED THAT THE PATIENT HAD HER FIRST FECAL EPISODE SINCE IMPLANT AND DID NOT CURRENTLY FEEL STIMULATION. THE PATIENT ADJUSTED SETTINGS FROM PROGRAM 2 AT 0.8 V TO 0.9 V AND STATED THAT SHE FELT STIMULATION WHEN TURNED UP. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION. THAT PATIENT HAD A LOSS OF BOWEL CONTROL, CONSTIPATION, AND A LOSS OF BLADDER CONTROL. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. THE SYMPTOMS OCCURRED AT THE PATIENT'S PERINEUM. THE IMPLANT HAD "HELPED SOME" WITH THE PATIENT'S FECAL INCONTINENCE. IT HAD HELPED WITH THE PATIENT'S BOWEL INCONTINENCE FOR "A COUPLE MONTHS," BUT NOW THE PATIENT WAS VERY CONSTIPATED. PATIENT PROGRAMMER USE WAS REVIEWED WITH THE PATIENT AND SHE DID NOT KNOW IF SHE HAD MORE THAN ONE PROGRAM OR NOT. THE PATIENT GOT POOR COMMUNICATION WITH AND WITHOUT THE ANTENNA, EVEN WITH ASSISTANCE. THE PATIENT HAD NEVER HAD TROUBLE COMMUNICATING BEFORE. THE PATIENT HAD NEVER CHANGED THE BATTERIES, SO REPLACED THEM. THE PATIENT WAS THEN ABLE TO SYNC AND STIMULATION WAS ON. THE PATIENT SWITCHED TO PROGRAM 3 AND INCREASED TO 0.9 VOLTS, BUT FELT NO STIMULATION. THE PATIENT INCREASED TO 1.0 VOLTS AND FELT STIMULATION. AFTER WALKING, THE PATIENT DECREASED BACK TO 0.9 VOLTS. EIGHT DAYS LATER IT WAS REPORTED THAT THE PATIENT STILL HAD CONSTIPATION. THE PATIENT'S HEALTH CARE PROVIDER (HCP) REQUESTED THAT THE PATIENT TURN STIMULATION OFF. THE PATIENT WAS ASSISTED IN MAKING SURE THE DEVICE WAS OFF. THE PATIENT WAS INDICATED FOR FECAL CONTROL, BUT WAS TOLD THAT SHE COULD GET SOME URINARY CONTROL. HOWEVER, THE PATIENT'S URINARY CONTROL HAD BEEN BAD SINCE IMPLANT AND SHE USED MULTIPLE PADS OR "DEPENDS" AND RUBBER PANTS AND TOWELS. THE PATIENT HAD NOT SEEN HER HCP SINCE IMPLANT AND HAD NOT TRIED PROGRAM 4 YET. THREE DAYS LATER, IT WAS REPORTED THAT THE PATIENT REALIZED THAT AFTER TURNING THE DEVICE OFF HOW MUCH SHE NEEDED THE DEVICE FOR CONTROL. THE PATIENT WAS ASSISTED IN TURNING THE DEVICE BACK ON AND SWITCHED TO PROGRAM 2 BECAUSE SHE NEVER EXPERIENCED CONSTIPATION WITH PROGRAMS 1 OR 2. THE PATIENT FELT STIMULATION COMFORTABLY AT 0.7 VOLTS. TWO DAYS LATER IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS OFF FOR THE "ENTIRE WEEKEND." THE PATIENT HAD RECTAL AND BLADDER INCONTINENCE "ALL WEEKEND." THE PROGRAM THE PATIENT ENDED ON IN THE PREVIOUS REPORT WAS BETTER BUT SHE STILL HAD INCONTINENCE. THE PATIENT HAD NO FALLS OR TRAUMA AND STATED THAT HER DEVICE "FELT FINE." THE PATIENT WAS ASSISTED IN INCREASING TO 0.8 VOLTS AND SHE PLANNED ON STAYING AT THIS SETTING. TWO DAYS LATER IT WAS REPORTED THAT THE PATIENT'S LAST INCREASE IMPROVED HER FECAL INCONTINENCE BUT WAS "NOT QUITE ENOUGH." THE PATIENT SETTLED AT 0.9 VOLTS AFTER 1.0 SEEMED "A LITTLE HIGH FOR HER." ADDITIONAL INFORMATION STATED THE PATIENT'S STIMULATOR WAS FOR BOTH "BLADDER AND FECAL" INCONTINENCE AND HAD "NOT HELPED THE BLADDER AT ALL." IT WAS REPORTED THE STIMULATOR "WAS HELPING FECAL, THEN ALL OF A SUDDEN THE PATIENT HAD ACCIDENTS." IT WAS NOTED THE STIMULATION "WORKED FOR SIX MONTHS" ON PROGRAM 1. THE PATIENT REPORTED HER ISSUES STARTED "ONE MONTH" PRIOR TO REPORT. IT WAS STATED THAT WHEN HER STIMULATION "STOPPED WORKING" SHE TRIED PROGRAM 3 AND THAT HAD "NOT HELPED." AT THE TIME OF REPORT, THE PATIENT WAS NOTED TO HAVE BEEN ON PROGRAM 2 AND 0.9 VOLTS. UPON INCREASE TO 1.0 VOLTS, THE PATIENT FELT "STIMULATION IN HER VAGINA, RECTUM, AND BUTTOCK AREA." THE PATIENT NOTED THAT "AT 0.9 VOLTS SHE HAD NO HELP AT ALL OR 0% HELP AND HAD A LOT OF LEAKAGE." THE PATIENT NOTED HER NEXT STEP WOULD BE TO TRY PROGRAM 4. IT WAS STATED THE PATIENT HAD NOT SEEN HER HEALTH CARE PROVIDER (HCP) SINCE HER STIMULATOR WAS IMPLANTED. THE PATIENT WAS REDIRECTED TO HER HCP. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 334309 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |