INTERSTIM II
Report
- Report Number
- 3004209178-2014-19913
- Event Type
- Malfunction
- Date Received
- October 17, 2014
- Report Date
- September 24, 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
- NJ, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT: PRODUCT ID 3889-28, LOT# VA0KHG5, IMPLANTED: 2013-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID NEU_PTM_PROG, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
(B)(4)
IT WAS REPORTED THE PATIENT HAD NO STIMULATION SENSATION AND A LOSS OF THERAPEUTIC EFFECT. STIMULATION FELT LIKE IT WAS ROAMING AROUND. WHEN STIMULATION SETTLED DOWN ON A LOCATION, THE SITE WOULD BE SORE. URINATION WOULD THEN BE BOTHERSOME AND BURN FOR A COUPLE OF DAYS. WHEN THE PATIENT LAID DOWN, THEY HAD TO MAKE SURE THEY WERE IN A POSITION WHERE THE ANTENNA WOULD NOT SLIP. STIMULATION HELPED THE LEFT SIDE MORE THAN THE RIGHT SIDE. THE PATIENT FELT A ¿CHARGE¿ AND HAD INCREASED FREQUENCY AFTERWARDS. THE PATIENT WAS EXPERIENCE INCONTINENCE. THE PATIENT HAD STIMULATION INCREASED TO 8.0 V AND DID NOT FEEL ANYTHING. NO FALLS OR TRAUMAS WERE ASSOCIATED WITH THE ISSUE. SEVERAL WEEKS LATER, THE PATIENT STILL HAD INCREASED FREQUENCY AND THEIR LOWER STOMACH AND VAGINA WERE SORE. CHANGING THE PROGRAM AND ADJUST STIMULATION DID NOT RESOLVE THE ISSUE. THE PATIENT EXPERIENCED A BUZZING SENSATION AT THE STIMULATOR SITE, BELOW THE SITE, IN THEIR THIGH, AND IN THEIR VAGINA. THE BUZZING WAS UNCOMFORTABLE. THE PATIENT TURNED STIMULATION OFF. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
IT WAS REPORTED TEN DAYS LATER THAT THE PATIENT WOULD LIKE TO MEET WITH A REPRESENTATIVE TO HAVE THE DEVICE CHECKED. HER SYMPTOMS HAVE RETURNED AND SHE HAS INCREASED STIMULATION TO 8 VOLTS AND WAS NOT FEELING ANYTHING. THE PATIENT WAS NOT FEELING STIMULATION THERAPY. THE HEALTHCARE PROVIDER TALKED TO THE PATIENT ABOUT ORAL MEDICATION BUT HAS NOT CHECKED THE DEVICE. THE PATIENT WAS STILL NOT FEELING STIMULATION. THE PATIENT SHUT STIMULATION OFF BECAUSE SHE GOT A VERY BAD VIBRATION. A COUPLE OF DAYS AGO SHE TURNED STIMULATION ON BUT SHE ONLY FELT STIMULATION IN HER LEFT CHEEK AND SHE STARTED TO GET SORE IN THE VAGINAL AREA. THE PATIENT TURNED OFF BECAUSE IT WAS MAKING HER TOO SORE. IT WAS REPORTED THAT HER FIRST INS(STIMULATOR) WAS REPLACED AFTER LESS THAN 1 YEAR OF BEING IMPLANTED. IT WAS UNKNOWN IF THE STIMULATOR WAS REPLACED DUE TO A MALFUNCTION OR NORMAL BATTERY DEPLETION. TWO DAYS LATER IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO MEET WITH HER HEALTHCARE PROVIDER ON (B)(6) 2014. IT WAS NOTED THAT THE REPRESENTATIVE HAVE NOT SPOKEN TO THE PATIENT.
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD RETURN OF SYMPTOMS AND THE STIM WAS NOT CONTROLLING HER SYMPTOM. THE PATIENT MET WITH THE MANUFACTURER REPRESENTATIVE AT THE CLINIC ABOUT 1-2 WEEKS AGO AND SHE WAS UNDER THE IMPRESSION THAT HER STIMULATION MAY HAVE BEEN TURNED OFF. THE PATIENT STATED IT WAS HER UNDERSTANDING THAT THEY HAD DECIDED TO TAKE A BREAK AND SAVE "WEAR AND TEAR" ON HER MACHINE. THE PATIENT WAS WONDERING IF THE NEUROSTIMULATOR (INS) WAS TURNED OFF AND IF SHE WAS SUPPOSED TO TURN IT BACK ON. IT WAS ALSO MENTIONED THAT PATIENT WAS ON A NEW MEDICATION (MYRBETRIQ) FOR ABOUT 1-2 WEEK NOW.
THE PATIENT LATER REPORTED THAT PATIENT MET WITH MANUFACTURER REPRESENTATIVE A COUPLE REGARDING THE ISSUE. THE PATIENT WAS FEELING STIMULATION BEFORE AND THEN ALL OF A SUDDEN SHE STOPPED FEELING IT. THE PATIENT REPORTED THAT THEY WERE GETTING SYMPTOM CONTROL. THE PATIENT INDICATED THAT SHE WAS GOING TO THE BATHROOM MORE FREQUENTLY. IT WAS NOTED THAT NO DIAGNOSTIC IMAGING WAS PERFORMED. THE PATIENT STATED THAT ¿HER SETTINGS SHE WAS ONE WHEN THE THERAPY WAS WORKING WAS AROUND 6.7-7.0 V SOMETHING IN THAT AREA.¿ THE PATIENT WAS ON PROGRAM 1 AT 8.0 V; PATIENT TRIED TURNING IT UP TO 8.4 V AND STILL DID NOT FEEL ANYTHING.
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT SHE HAD A LOSS OF THERAPY. THE PATIENT HAD NOT HAD URINARY RELIEF SINCE MARCH AND HAD BEEN TRYING TO GET HER DOCTOR'S HELP. THE PATIENT WAS ON PROGRAM 1 AT 7.90V AT THE TIME OF THIS REPORT. THE PATIENT HAD TO TURN IT UP HIGHER AND THERE WERE A FEW TIMES WHEN SHE TURNED STIMULATION UP THAT SHE FELT A BURNING SENSATION. THE PATIENT DID NOT FEEL STIMULATION AT THE TIME OF THIS REPORT AND THERAPY WAS CONFIRMED TO BE ON. THE PATIENT WAS IMPLANTED FOR URINARY DYSFUNCTION AND GASTROINTESTINAL/ PELVIC FLOOR ISSUES.
ADDITIONAL INFORMATION RECEIVED LATER INDICATED THAT IT WAS STILL NOT WORKING FOR PATIENT AND WAS EXPERIENCING LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT PATIENT SAW THEIR HEALTH CARE PROVIDER ABOUT A MONTH AGO AND HE PRESCRIBED HER SOME ORAL MEDICATION TO HELP HER WITH HER BLADDER SYMPTOMS. THE PATIENT REPORTED THAT SHE DID HAVE SUCCESS WITH THE TRIAL DEVICE AND INITIALLY THE THERAPY WORKED FOR HER POST IMPLANT FOR A COUPLE OF WEEKS. INFORMATION RECEIVED LATER ON (B)(6) 2015 INDICATED THAT PATIENT HAD GOOD THERAPY FOR ABOUT 2 WEEKS AND HAD BEEN HAVING PROBLEMS THE PAST 3-5 MONTHS. THE PATIENT WAS CURRENTLY GOING TO THE BATHROOM EVERY HOUR OR LESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 661514 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00081 YR |