INTERSTIM II
Report
- Report Number
- 3004209178-2014-10160
- Event Type
- Injury
- Date Received
- June 4, 2014
- Report Date
- May 13, 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
- NY, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT# VA07HNZ, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
(B)(4).
IT WAS REPORTED THAT THE PATIENT HAD MRI IN OCTOBER, FOR BACK PAIN WHILE SHE WAS IN ER. THE PATIENT NOTIFIED THE MANUFACTURER'S REPRESENTATIVE AFTER SHE HAD THE MRI. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. THIS OCCURRED FOLLOWING A FALL. IN (B)(6) 2013 THE PATIENT HAD A REALLY BAD FALL. SHE HIT HER HEAD ON SECURITY CAR AND ENDED UP SEATED RIGHT AGAINST THE CAR. THE PATIENT WAS HAVING PROBLEMS WITH IMPLANT AND WANTED TO KNOW IF CAN HAVE DEVICE REMOVED. THE PATIENT NOTIFIED THE MANUFACTURER'S REPRESENTATIVE AFTER HER FALL AND HE CHECKED HER DEVICE IN (B)(6) 2013. THE PATIENT RECALLED THAT HE CHANGED SOME PROGRAMS. NO OTHER DIAGNOSTIC TESTS WERE MENTIONED. THE PATIENT NOTED SHE COULD ONLY FEEL ABOUT 1/4 OF THE INS NOW AND SHE DIDN'T FEEL STIMULATION EXCEPT WHEN SHE URINATES WHEREAS BEFORE SHE FELT STIMULATION ALL THE TIME. PATIENT SERVICES ASKED THE PATIENT TO CHECK IMPLANTABLE NEUROSTIMULATOR (INS) DURING CALL BUT THE PATIENT SAID THAT PROGRAMMER WOULDN'T GO BEYOND HOME SCREEN. IT WAS LATER REPORTED THAT THE PATIENT ALSO HAD A MRI OF HER STOMACH IN NOVEMBER. REGARDING IF THE PATIENT HAD THE DEVICE CHECKED AFTER THE MRI THE PATIENT NOTED SHE CALLED THE MANUFACTURER'S REPRESENTATIVE AND HE ASKED HER IF SHE WAS HAVING ANY PROBLEMS AND SHE SAID NO, SO THE DEVICE WAS NOT CHECKED. THE PATIENT CALLED IN BECAUSE SHE WOULD LIKE TO HAVE HER DEVICE REMOVED. EVERY TIME THE PATIENT WOULD GO TO THE BATHROOM SHE GETS A STIM SENSATION - THIS STARTED ABOUT 2 WEEKS AGO. THE PATIENT HAD TO WEAR A PAD AND SHE HAD TO CHANGE THE PAD ABOUT EVERY 2 HOURS - THIS STARTED ABOUT 2 WEEKS AGO. THE PATIENT FELL IN (B)(6) AND BELIEVED SHE DAMAGED THE DEVICE. THE PATIENT SAW THE MANUFACTURER'S REPRESENTATIVE AND THE HCP (HEALTHCARE PROVIDER) IN (B)(6) AND THEY SAID THE DEVICE WAS NOT DAMAGED. THE PATIENT NOTED THE DEVICE/IMPLANT WAS GETTING SMALLER. IT WAS 4 INCHES NOW WAS DOWN TO 2 IN. THIS STARTED A WEEK AFTER THE FALL. THE PATIENT SAID NOT THE TIP OF HER THUMB IS BIGGER THAN THE IMPLANT. THE PATIENT NOTED NO WEIGHT GAIN OR WEIGHT LOSS. THE PATIENT PUT ALKALINE BATTERIES IN THE PATIENT PROGRAMMER AND WAS ABLE TO INCREASE STIM. NO MATTER HOW HIGH THE PATIENT INCREASED STIM IT DIDN'T HELP WITH HER SYMPTOMS. THE PATIENT COULD FEEL STIM BUT IT DIDN'T HELP WITH HER SYMPTOMS. REGARDING WHEN THIS WAS, THE PATIENT SAID IN (B)(6). WHEN THE PATIENT SAW THE MANUFACTURER'S REPRESENTATIVE AND HCP IN (B)(6) THE HCP GOT UPSET AND HAD TO LEAVE THE ROOM. THE PATIENT WENT TO THE HCP IN (B)(6) BECAUSE SHE WAS URINATING MORE. THE PATIENT NOTED THE HCP PANICKED AND LEFT THE ROOM. THE PATIENT MENTIONED SHE WAS SURE SHE HAS A UTI. THE PATIENT NOTED SHE HAD A UTI AND THIS STRAIGHTENED OUT. THE PATIENT HAS TO HAVE A BIOPSY ON HER THROAT. THE PATIENT DIDN'T THINK SHE WOULD BE ABLE TO LAY FLAT FOR 3.5 HOURS (LENGTH OF BIOPSY) BECAUSE OF HER INCONTINENCE. THE PATIENT GOES TO THE BATHROOM MUCH MORE THAN EVER BEFORE. THE PATIENT HAD NEVER HAD A PROBLEM WITH HER THYROID UNTIL RECENTLY. THEY DO A SCAN OF HER THYROID EVERY YEAR TO 6 MONTHS AND NEVER FOUND ANYTHING UNTIL RECENTLY, THEY FOUND 4 SPOTS. THE PATIENT MADE THE ALLEGATION THAT THE DEVICE WAS LEAKING AND WAS POSSIBLY CAUSING THE ISSUES WITH HER THYROID. THE PATIENT WAS BEING TESTED FOR THYROID CANCER. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
IT WAS LATER REPORTED THAT THE INS WAS NOT THE SAME SIZE IT WAS AT IMPLANT, THE PATIENT THOUGHT IT SHRANK TO ABOUT 1/4 OF THE SIZE. THE INS WAS NOT WORKING FOR THERAPY, IT GOES ALL THE TIME ON HER BOWELS AND THE PATIENT WAS CONSTIPATED. THIS STARTED NOVEMBER LAST YEAR (2013) SINCE THIS TIME THE PATIENT HAD ALSO HAD MANY UTI- INFECTIONS THAT HCP (HEALTHCARE PROVIDER) HAS GIVEN THE PATIENT PILLS FOR. REGARDING WHEN DID THE EVENT OR SYMPTOMS OCCUR, IT WAS NOTED FOLLOWING A FALL -- THE PATIENT HAD A BAD FALL IN (B)(6) 2013. IT WAS ALSO NOTED: FOLLOWING AN UNRELATED MEDICAL PROCEDURE. IN (B)(6) 2013 THE PATIENT ALSO WENT TO AN ER WHERE AN MRI WAS PERFORMED ON THE PATIENT. THE PATIENT DIDN'T KNOW IF THE ABOVE ISSUES WERE CAUSED BY THE FALL, MRI OR BOTH. WHILE THE PATIENT WANTED THE DEVICE EXPLANTED, THEY HAD NOT REQUESTED EXPLANT FROM HCP. IT WAS NOTED THAT A MANUFACTURER'S REPRESENTATIVE WAS NOTIFIED OF ALL EVENTS IN (B)(6) 2013 AND HAD WORKED WITH THE PATIENT ON PROGRAMMING MULTIPLE TIMES. IT WAS NOTED THAT THE REPRESENTATIVE CAN USUALLY FIX/RAISE STIM TO WORK AGAIN DURING SESSIONS.
IT WAS LATER REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT HAD A CT SCAN IN AN EMERGENCY SITUATION IN OCTOBER AND AFTER THE CT SCAN THEIR THERAPY DIDN'T WORK FOR THEM. THE PATIENT WANTED THEIR THERAPY TAKEN OUT SINCE OCTOBER AND THE MANUFACTURER REPRESENTATIVE HAD TRIED TO HELP WITH REPROGRAMMING ON THREE SEPARATE OCCASIONS SINCE THEN BUT NOTHING HELPED. THE PATIENT STATED THEY NEEDED TO HAVE SURGERY IN MARCH. THE PATIENTS SYMPTOMS WERE WORSE THAN BEFORE IMPLANT AND THEY HAD TO USE A LOT OF PADS.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH HER DEVICE OR THERAPY AND WAS WORKING WITH THE DOCTOR OR MANUFACTURER REPRESENTATIVE. THE PATIENT RESTATED HER DESIRE TO GET THE IMPLANT REMOVED. IT WAS STATED THAT THE IMPLANT WAS NOT BRINGING RELIEF. THE PATIENT THOUGHT THE IMPLANT FELT SMALLER AND WAS NOT WORKING. THE PATIENT WAS SEEN BY THE HCP AND MANUFACTURER REPRESENTATIVE AND FOUND NO ISSUE, BUT THE PATIENT THOUGHT THEY WERE WRONG. IT WAS NOTED THAT THE PATIENT ALSO HAD OTHER MEDICAL PROBLEMS.
ADDITIONAL INFORMATION RECEIVED NOTED THAT THE MANUFACTURER'S REPRESENTATIVE DIDN'T HAVE AN EXACT DATE FOR WHEN HE WAS AWARE OF THE EVENTS BUT KNEW THAT THE FIRST THING HE WAS AWARE ABOUT WAS THE INS SIZE ISSUE. THE PATIENT PROBABLY TOLD HIM ABOUT THAT IN (B)(6) OF 2013 AND HE DIRECTED THEM TO THEIR PHYSICIAN. THE PATIENT HAD MEMORY TROUBLES AND WAS EASILY CONFUSED. THE PATIENT WENT TO THE OFFICE AND THE DOCTOR HAD HER PLACE HER HAND ON A DEMO INS AND COMPARE IT TO HERS AND SHE WAS AT EASE WITH THE SIZE. THE MANUFACTURER'S REPRESENTATIVE REPORTED HE DIDN'T HAVE DATES FOR WHEN THIS HAPPENED, BUT THEY ALSO REPROGRAMMED HER. ABOUT THREE WEEKS AGO, THE MANUFACTURER'S REPRESENTATIVE GOT A CALL FROM THE PATIENT SAYING THAT THEY WANTED TO HAVE THEIR INS REMOVED, AND HE DIRECTED THEM TO THEIR DOCTOR TO SET UP AN APPOINTMENT. THE MANUFACTURER'S REPRESENTATIVE HADN'T HEARD ANYTHING ELSE FROM THE PATIENT OR THE OFFICE REGARDING THE PATIENT. REGARDING IF THE PATIENT HAD 50% OR GREATER SYMPTOM REDUCTION, THE REPRESENTATIVE SAID THEY DID INITIALLY BUT HAD NO IDEA WHEN THAT CHANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 325897 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Required Intervention |