INTERSTIM II
Report
- Report Number
- 3004209178-2013-08278
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Report Date
- May 8, 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
- PA, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# J0545165V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
(B)(4).
(B)(4).
IT WAS REPORTED THAT FOLLOWING DEVICE REPLACEMENT THE PATIENT HAD HAD A INCREASED BACKACHE WHICH HAD PROGRESSED TO HER RIGHT HIP TO GROIN TO LEG AND KNEE, SOMETIMES PREVENTING HER FROM WALKING OR STANDING ON IT. IT WAS NOT UNUSUAL FOR THE PATIENT TO HAVE BACK PAIN, AS SHE HAD HAD 3 BACK SURGERIES IN THE PAST ((B)(6) 2010, 1995, AND IN 1986). THE PATIENT COULD NEVER REALLY FEEL THE STIM SENSATION SINCE THE REPLACEMENT ON (B)(6) 2013. THE PATIENT HAD TRIED ALL PROGRAMS AND STILL COULD NOT FEEL THE STIM. THE PATIENT WAS SEEN ON (B)(6) FOR THIS ISSUE AND THEY TRIED TO REPROGRAM THE DEVICE. THE PATIENT ONLY FELT A SLIGHT SENSATION, BUT IT FELT LIKE A STRANGE FEELING LIKE A "MOVING BUBBLE". THE PATIENT OVERHEARD THE DOCTOR IN THE HALLWAY TELLING SOMEONE THAT HE HAD TO CALL THE MANUFACTURER ABOUT THIS. THE DOCTOR ADVISED THE PATIENT TO TURN THE STIM OFF FOR TWO WEEKS AND RELY ON ORAL MEDS TO SEE WHAT HAPPENED. SINCE THE PATIENT TURNED THE STIM OFF, SHE HAD BEEN GETTING UP 4-5 TIMES PER NIGHT. THE PATIENT CALLED THE HCP THE NEXT DAY AND WAS TOLD BY THE OFFICE TO KEEP THE STIM OFF FOR 2 WEEKS AND TAKE THE ORAL MEDS AND SEE WHAT HAPPENED. THE PATIENT THEN TRIED AGAIN THE NEXT DAY TO CALL AND ASK THE SAME THING AND WAS TOLD THE SAME INFORMATION. THE PATIENT WAS NOT SEEING AN IMPROVEMENT IN BACK PAIN WITH THE DEVICE OFF. THE PATIENT WAS NOT SURE WHETHER OR NOT OR HOW MUCH SYMPTOM RELIEF THAT SHE WAS GETTING WITH THE STIM TURNED ON. THE PATIENT LIVED ALONE AND IS VERY ACTIVE, YARD WORK, SWIMMING, ETC. THE PATIENT PLANNED TO SEE A NEUROSURGEON FOR HER BACK PAIN. IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT WAS HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR PHYSICIAN - APPT (B)(6) 2013. IT WAS NOTED THAT THE PATIENT WAS STILL TRYING TO DEAL WITH PAIN IN RIGHT HIP TO RIGHT KNEE. THEY TRIED LEAVING DEVICE OFF FOR 2 WEEKS AND THERE WAS NO RELIEF. THE LAST VISIT TO THE DOCTOR, THEY TOLD HIM THAT THE DEVICE WAS NOT WORKING. THE DEVICE WAS REPROGRAMMED TO LEADS 5 6 7 8 INSTEAD OF 1 2 3 4. THEY TRIED THE DEVICE ON LEAD 5 AT 0.4 AND HAD THE SAME PAIN AFTER WALKING TO THE CAR. UNDERLYING, WAS THE PATIENT'S CHRONIC BACK PROBLEM. THEY HAD 3 SURGERIES, THE LAST ONE IN (B)(6) 2010. THEY WERE DOING PRETTY WELL, BUT WHEN THEY WORKED IN THE YARD, ETC. THEY DEVELOPED PAIN WHICH WAS NORMALLY RELIEVED WITH TYLENOL AFTER A FEW DAYS. THIS HAPPENED AGAIN A COUPLE OF WEEKS BEFORE THE BATTERY CHANGE. AFTER THE BATTERY CHANGE, THEY NEEDED TYLENOL # 3 FOR THE PAIN IN RIGHT HIP. THE PATIENT HAD X-RAYS (B)(6). THE PATIENT KNEW THEY NEEDED SURGERY AGAIN ON L3, L4, L5 AND S1 BUT HAD BEEN ABLE TO AVOID IT. THIS IS WHY THE DOCTOR THOUGHT THE PAIN WAS NOT COMING FROM THE DEVICE. THE PATIENT'S THOUGHT AT THIS POINT WAS HAVING THE DEVICE ON OR OFF IS NOT THE PROBLEM. SOMETHING CHANGED AT THE BATTERY REPLACEMENT PROCEDURE AND WHY DOESN'T IT WORK ANYWAY. THE PATIENT DID NOT WANT IT REMOVED AND DID NOT WANT TO HAVE BACK SURGERY. THE DOCTOR SAID X-RAYS WOULD NOT SHOW ANYTHING. IT WAS NOTED THAT TODAY THE PATIENT HAD TINGLING DOWN THEIR LEG AND PAIN YESTERDAY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
IT WAS LATER REPORTED THAT FOLLOWING A DEVICE REPLACEMENT THE PATIENT HAD PAIN GOING DOWN THEIR LEG. THE PATIENT WAS WONDERING: "CAN YOU HAVE JUST THE BATTERY CHANGED IN THE INTERSTIM?" THE PATIENT THOUGHT THE DOCTOR WAS ONLY GOING TO REPLACE THE "BATTERY," NOT THE ENTIRE STIMULATOR. THE PATIENT NOTED THEY "HAD SO MUCH DISCOMFORT AFTER THE SURGERY. THE DOCTOR KEPT SAYING 'ALL WE DID WAS CHANGE THE BATTERY. THE LEADS AND EVERYTHING ARE STILL IN THE SAME PLACE. WE DIDN'T DISTURB ANYTHING.' THE PATIENT HAD QUESTIONS REGARDING IF THE NEUROSTIMULATOR "EMBEDS ITSELF IN THE TISSUE. IT'S BEEN IN THERE 7 YEARS." AND IF IT EMBEDS ITSELF, "HOW LONG WILL IT TAKE TO REMOVE AND HAVE A NEW ONE PUT IN?"THE PATIENT HAD QUESTIONS REGARDING IF THE LEAD NEEDED TO BE CHANGED WHEN THE INTERSTIM WAS CHANGED? THE PATIENT NOTED THIS HAD "BEEN VERY CONFUSING TO ME BECAUSE I HAD SO MUCH TROUBLE AFTERWARDS WITH PAIN." THE PATIENT KEPT THINKING THAT "JUST THE BATTERY" WAS CHANGED, "HOW COULD THIS BE SO PAINFUL?" THE PATIENT NOTED THEY: "COULD NOT EVEN PUT THEIR FOOT DOWN ON THE GROUND AND WALK." THE PATIENT NOTED: "I ALREADY HAVE A BACK PROBLEM" SO THE IMMEDIATE THOUGHT WAS THE PAIN WAS THE RESULT OF THE BACK PROBLEM. THE PATIENT DID NOT REALIZE THEY HAD A NEW STIMULATOR, THEY THOUGHT THE CASE WAS OPENED UP AND "IT WAS JUST A BATTERY CHANGE." THE PATIENT THOUGHT IT WAS SIMILAR TO REPLACING A BATTERY IN A CAMERA. IT WAS NOTED THAT THE PAIN AFTERWARDS WAS GOING DOWN THEIR LEG. AT THE PATIENT'S POST-OP APPT, THE PATIENT NOTED: "THIS IS NOT WORKING." WHEN THE INS WAS CHECKED BY OFFICE STAFF, THEY INFORMED THE DOCTOR THAT THE PATIENT WAS NOT FEELING ANYTHING. THE DOCTOR SUGGESTED THE PATIENT TURN THE STIM OFF FOR 2 WEEKS. EVEN WITH THE INS OFF, THE PATIENT NOTED:"I HAD ALL THE PAIN." THE PATIENT THEN MADE AN APPOINTMENT TO SEE THEIR NEUROSURGEON. X-RAYS WERE TAKEN. BY THE TIME THE PATIENT SAW THE DOCTOR (A MONTH LATER) THE PAIN WAS ALMOST GONE. THE PATIENT DID TURN THE INS OFF FOR 2 WEEKS, BUT THE PAIN WAS STILL THERE. WHEN THE PATIENT SAW THE DOCTOR, HE SAID "IT'S L5 THAT'S GIVING YOU A PROBLEM" AND WANTED TO PLACE A ROD, BUT THE PATIENT TALKED HIM OUT OF IT. THE PATIENT WAS TOLD BY A DOCTOR THAT THE INS CAN BE TAKEN OUT. ANOTHER DOCTOR TOLD THE PATIENT THEY WOULD HAVE MORE PAIN IF THE INS WAS TAKEN OUT AND REPLACED, THAN IF HE FIXED L5. ( IT WAS NOTED: THE TUNNEL FOR THE NERVE IS "GETTING SMALLER AND SMALLER BECAUSE YOU HAVE ARTHRITIS AND IT'S COMPRESSING THE NERVE"). THE PATIENT DID NOT WANT A THIRD BACK SURGERY. THE PATIENT NOTED HOW CONFUSING THIS HAS BEEN. THE PATIENT NOTED: THEY ARE "ALMOST BACK TO NORMAL." THE PAIN AFTER THE REPLACEMENT HAD LET UP A LOT. "IT'S ALL BETTER NOW." THE PATIENT HAD HAD BACK PROBLEMS SINCE 1986 WHEN LIFTING A PATIENT. IT WAS NOTED THE PATIENT SWIMS A LOT. THE ISSUE WITH L5 WILL BE MONITORED. THE PATIENT EXPRESSED FRUSTRATION THAT THE OFFICE DID NOT TRY DIFFERENT SETTINGS AT THE FIRST POST- OP VISIT RATHER THAN TELLING THEM TO TURN IT OFF. THE PATIENT NOTED: "I FEEL 100% BETTER."
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD ISSUES WITH THEIR HEALTH CARE PROVIDER¿S (HCP¿S) OFFICE SECRETARY AND ULTIMATELY CHANGED HCPS BECAUSE THEY WERE NOT DIAGNOSING THEIR PAIN CORRECTLY AND TOLD THE PATIENT THAT THEIR PAIN HAD NOTHING TO DO WITH THE DEVICE. THE PATIENT¿S NEW HCP CONFIRMED THAT YES THE DEVICE WAS THE CAUSE OF THEIR REPORTED PAIN. IT WAS REPORTED THAT THE PATIENT SUFFERED FOR THE SUMMER AND THE FALL UNTIL THEY WERE PROPERLY DIAGNOSED. THE PATIENT¿S MANUFACTURER REPRESENTATIVE HELPED THE PATIENT SWITCH HCPS.
PATIENT WAS PRESCRIBED A MEDICATION FOR INCONTINENCE AT THAT TIME, WHICH THEY WERE CURRENTLY TAKING. IT WAS NOTED THAT PATIENT HAD EXPERIENCED SOME LEAKING "A LITTLE BIT." IT WAS REPORTED THAT PATIENT DIDNT HAVE ANY PROBLEMS WITH THEIR PREVIOUS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235711 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR |