INTERSTIM II
Report
- Report Number
- 3004209178-2014-11632
- Event Type
- Injury
- Date Received
- June 16, 2014
- Date of Event
- January 1, 2013
- Report Date
- December 6, 2016
- 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
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4)
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4).
ANALYSIS RESULTS ON THE LEAD SHOWED NO SIGNIFICANT ANOMALIES WITH NOTES OF THE LEAD BODY CUT THROUGH/PRODUCT SEGMENTED PRESCRIPTION: MEDFORMIN. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PATIENT CODE (B)(4) IS NO LONGER APPLICABLE TO THE EVENT.
(B)(4).
FINAL ANALYSIS OF THE INTERSTIM NEUROSTIMULATOR (B)(4) REVEALED NO SIGNIFICANT ANOMALY AND FUNCTIONALLY OKAY.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V396221, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).
IT WAS REPORTED THAT SOMETHING HAD BEEN BOTHERING A PATIENT FOR TWO MONTHS ¿BUT IT REALLY STARTED THREE MONTHS AGO.¿ IT WAS NOTED THAT THE PATIENT HAD PAIN FROM UNDER THE NAVEL, ¿ALL THE WAY ACROSS,¿ AND THEN ALL THE WAY AROUND THE BACK. THE REPORTER STATED THAT THE PATIENT HAD PAIN WHEN SHE BENT OVER, SHE COULDN¿T STAND UP STRAIGHT, SHE COULD HARDLY WALK, AND SHE HAD AN EXTREMELY DIFFICULT TIME GETTING OUT OF BED AS SHE NEEDED TO ¿SLEEP CROSSWISE SOMEWHAT ON HER STOMACH¿ AND HAD TO PULL HERSELF TO THE EDGE OF THE BED WHICH WAS EXTREMELY PAINFUL. IT WAS REPORTED THAT BECAUSE OF THE PAIN IT TOOK HER SO MUCH TIME TO GET OUT OF BED THAT SHE COULDN¿T MAKE IT TO THE BATHROOM AND STARTED PEEING ON HER WAY TO THE BATHROOM. IT WAS NOTED THAT THE PAIN WOULD ¿JUST GRAB¿ THE PATIENT AND SHE HAD TO LIFT HER LEG IN ORDER TO GET INTO THE CAR. IT WAS REPORTED THAT THE PATIENT WAS CONSTIPATED AND TOOK SUPPOSITORIES FOR THREE DAYS BUT IT DIDN¿T MAKE A DIFFERENCE. THE PATIENT HAD A LOT OF TESTS AND HAD SEEN THREE HEALTHCARE PROVIDERS BUT THEY COULDN¿T FIND ANYTHING WRONG. THE TESTS INCLUDED A COLONOSCOPY, CT SCAN, ULTRASOUND, EKG, AND STRESS TEST. IT WAS REPORTED THAT THE PATIENT CALLED A DOCTOR AND WAS DIRECTED TO TURN STIMULATION OFF BUT SHE NEEDED INSTRUCTION ON HOW TO DO SO. STIMULATION WAS AT 1.3 VOLTS AND ON AND THE PATIENT WAS UNABLE TO COMPLETE TURNING IT OFF HERSELF AND WOULD HAVE SOMEONE ASSIST HER LATER. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2014. IT WAS LATER REPORTED THAT PATIENT COMPLAINT OF LEG PAIN, DEVICE WAS EXPLANTED .IT WAS INDICATED THAT IMPEDANCE TESTING, X-RAYS, REP ROGRAMMING WERE PERFORMED. IT WAS INDICATED THAT THERE WAS NO PRODUCT ISSUE THAT WAS RESOLVED AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PATIENT BELIEVED PAIN FROM INTERSTIM CAUSED BLADDER SPASMS. RIGHT LOWER BACK PAIN RADIATED TO LOWER ABDOMEN, BILATERAL THIGH PAIN, DIFFICULTY FLEXING HIPS, WEAKNESS IN LEGS. THE PAIN WORSE WHEN BENDING HER WAIST. (B)(6) 2014 PELVIC CT NEGATIVE. TURNING INTERSTIM OFF DID NOT HELP PAIN. KIDNEY STONES AND IC. BACK PAIN REMAINS AFTER INTERSTIM REMOVAL. THE PATIENT MEDICAL HISTORY WAS REPORTED AS HIGH BLOOD PRESSURE, IC. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE WITH NO INJURY¿ INFORMATION RECEIVED LATER INDICATED THAT PATIENT HAD IT REMOVED (B)(6) 2014, IT WAS GIVING HER PROBLEMS PAINFUL AND DID NOT WORK HALF THE TIME. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S INS WENT BAD INSIDE OF THEM. AT FIRST THE PATIENT COULDN'T BREATHE AND THEN THEY HAD SHOOTING PAIN FROM THEIR RIGHT BUTTOCK WHERE THE INS WAS PLACED. THE PATIENT HAD SEEN A HEART HEALTH CARE PROVIDER (HCP), HAD THEIR STOMACH LOOKED AT, AND HAD BEEN THOUGH EVERYTHING. 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.
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THE DEVICE WAS IMPLANTED IN THE RIGHT BUTTOCK. THERE WAS SWELLING IN THE LEFT LEG, MUSCLE SPASMS, PELVIC PAIN, AMBULATION DIFFICULTIES, LOSS OF RANGE OF MOTION, AND SHORTNESS OF BREATH. THE DEVICE WAS REMOVED BUT THE PATIENT STILL EXPERIENCED SYMPTOMS.
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THEY GOT SEVERE LOWER PELVIC PAIN FROM THE INTERSTIM DEVICE. IT WAS INDICATED THAT THE SYMPTOMS STARTED GRADUAL IN (B)(6) 2013. THERE WERE NO TRAUMAS REPORTED AT THE TIME OF THE EVENT. IT WAS INDICATED THAT PATIENT STARTED HAVING PAIN IN HER RIGHT LEG AND PAIN AT THE NEUROSTIMULATOR (INS) SITE. IT WAS INDICATED THAT THE PAIN STARTED TO COME IN THE LOWER PART OF HER STOMACH. IT WAS INDICATED THAT THE THERAPY HAD NOT BEEN WORKING FOR HER SYMPTOMS SINCE THE YEAR BEFORE AND SHE HAD TO KEEP GETTING IT REPROGRAMMED AND THE HEALTH CARE HAD TO JUST REMOVE IT. IT WAS INDICATED THAT ALL THE SYMPTOMS WENT AWAY AFTER THE DEVICE WAS EXPLANTED BUT THE PELVIC PAIN DID NOT GO AWAY AFTER EXPLANT. IT WAS INDICATED THAT HEALTH CARE PROVIDER GAVE PATIENT'S BLADDER INJECTIONS FOR IC AND PATIENT DID NOT HAVE IC. IT WAS INDICATED THAT THE INJECTIONS DID NOT HELP HER PAIN. THE PATIENT COULD HARDLY SIT DOWN WHILE SHE WAS GOING TO THE BATHROOM FROM PAIN. IT WAS INDICATED THAT PATIENT WAS HAVING BLADDER SPASM THAT STARTED 2 WEEKS BEFORE INTERSTIM WAS EXPLANTED. IT WAS INDICATED THAT IN (B)(6) 2014 THE BLADDER SPASMS GOT WORSE. IT WAS INDICATED THAT SINCE (B)(6) OF 2014 PATIENT COULD NOT SLEEP ON HER RIGHT SIDE AND THE PELVIC PAIN HAD GOTTEN WORSE. IT WAS INDICATED THAT WAS SENT TO HEART HEALTH CARE PROVIDER FOR SHORTNESS OF BREATH, THE PAIN WAS CUTTING OFF HER BREATH AND SHE STARTED TO WALK SLOWER. IT WAS NOTED THAT PATIENT STILL HAD PAIN WHERE THE INS WAS IMPLANTED DOWN TO HER RIGHT THIGH. SHE HAD TO WALK LIKE SHE WAS ON EGGSHELLS - IF SHE GOT BUMPED "THAT LOWER PELVIC PAIN WILL GRIP HER LIKE NO OTHER PAIN SHE HAD EVER HAD". IT WAS INDICATED THAT PATIENT CALL ON THE DAY OF THIS REPORT AND WAS CLAIMING THAT HER INTERSTIM DEVICE WAS DEFECTIVE AND WAS CAUSING HER PELVIC PAIN. IT WAS INDICATED THAT THE PATIENT WAS STILL CLAIMING THAT SHE WAS STILL SUFFERING WITH PAIN IN HER PELVIS / ABDOMEN AREA BECAUSE OF THE DEVICE AND SHE REQUESTED HEALTH CARE PROVIDER INFORMATION FOR SOMEONE THAT COULD HELP HER WITH INTERSTIM SIDE EFFECTS.
ADDITIONAL INFORMATION FROM THE PATIENT REPORTED THE PATIENT HAD THEIR INTERSTIM DEVICE SINCE 2013 AND HAD TWO SURGERIES. ONE WAS TO REPAIR THE WIRES AS THE INTERSTIM TIPPED A MONTH AFTER IMPLANT AND THEN COMPLETELY FLIPPED OVER DISCONNECTING WIRES. THE SECONDS SURGERY WAS TO IMPLANT THE DEVICE DEEPER INTO THEIR FAT CELLS, AS THE DEVICE , FOR THE SECOND TIME, SURFACED TO THE TOP OF THE THEIR SKIN AND TO FIX THE BATTERY. A MANUFACTURING REPRESENTATIVE STATED THE DEVICE HAD BEEN OFF SINCE 2014 AND THEY NEEDED TO PUT IN A NEW BATTERY. THE PATIENT NOTED, THEY WERE TOLD THE BATTERY WAS SUPPOSED TO LAST 5 TO 7 YEARS. AT THE TIME OF THE REPORT, THE PATIENT STATED THEY WANT TO DO A THIRD SURGERY TO MOVE THE DEVICE FROM THE LEFT SIDE TO THE RIGHT SIDE. HOWEVER, THE PATIENT STATED THAT THE DEVICE WAS SHOCKING THEM, CAUSING A BURNING SENSATION DOWN THEIR LEFT LEG AND HONESTLY HAD NEVER WORKED PROPERLY SINCE IMPLANT. THEY WANTED IT COMPLETELY REMOVED. THE PATIENT STATED THEY FELT LIKE A GUINEA PIG AND THEY WERE BEING CARVED ON AND SUFFERING. THE DEVICE WAS IMPLANTED AND WITHIN 10 DAYS THEY WERE IN PAIN AND HAD THE DEVICE REMOVED. SIX MONTHS LATER AND THEY REMAIN IN PAIN. THE PATIENT SAID THAT INVESTIGATIONS SHOWED THAT THERE WAS NERVE DAMAGE WHERE THE DEVICE HAD BEEN. THE TEMPORARY DEVICE HELPED THEIR INCONTINENCE, BUT THE PERMANENT NEVER HELPED THEIR INCONTINENCE AT ALL. THE PATIENT CLARIFIED, THEY ARE HAVING SIDE EFFECTS FROM THE IMPLANT THAT WAS PUT IN, IN 2010, AND REMOVED IN 2014 AND HAD STOPPED WORKING IN 2013. THEY CONTINUED TO EXPLAIN THAT THEIR LEFT FOOT SWELLS AND THE IMPLANT WAS IN THE RIGHT BUTTOCK CHEEK. THEY HAVE SPASMS THAT RUN ACROSS THEIR LOWER PELVIC AND ARE WORSE IN THEIR RIGHT LEG. THE PATIENT NOTED THEY DO NO HAVE IC OR PBS. THE TESTS THEY NOTED HAVING INCLUDED HEART, LUNG, ARTERIES, NERVE, 2 MRI'S, COLONOSCOPY, BLADDER INJECTIONS IN THE BLADDER, ULTRASOUNDS, CAT SCANS, STOMACH, X-RAYS, SPIN AND CHECKED FOR BLOOD CLOTS AND ALL CHECKS HAD COME BACK GOOD. THE TESTS STARTED IN 2013, AFTER HAVING TROUBLE. THEY DID NOT THINK IT WAS THE IMPLANT UNTIL 2014. THEY WENT IN AND HAD THE INS REMOVED. THEIR BACK PAIN WENT AWAY AND ONLY HURTS WHEN THEY LIE ON THEIR BACK AND TRY TO RISE UP. THE PATIENT NOTED THEY HAD TO STOP WORKING BECAUSE THEY COULD HARDLY BEND OVER AND PICK UP ANYTHING. THEY WOULD HAVE TOO MANY SPASMS ON THE RIGHT SIDE AND DOWN THE RIGHT LEG.
ADDITIONAL INFORMATION FROM THE HEALTHCARE PROFESSIONAL (HCP) PROVIDED THE PATIENT'S PRE-OP AND POST-OP SURGICAL RECORDS: THE PATIENT HAD AN ABDOMINAL ULTRASOUND ON (B)(6) 2014. THE PROCEDURE NOTED THAT THE THERE WAS A SIMPLE CYST IN THE RIGHT KIDNEY MEASURING 1.2CM. THERE WAS A CYST WITH A THIN INTERNAL SEPTATIONS IN THE LEFT KIDNEY AT THE LOWER POLE MEASURING 1.8CM THE PATIENT HAD A CT SCAN OF THE ABDOMEN AND PELVIS ON (B)(6) 2014. THE EXAMINATION OF THE ABDOMEN AND PELVIS WERE PERFORMED WITH THE USE OF ORAL AND IV CONTRAST MATERIAL ACCORDING TO STANDARD PROTOCOL. THE EXAMINATION OF THE ABDOMEN FOLLOWING IV AND ORAL CONTRAST REVEALS SOME MILD ENLARGEMENT OF THE LIVER WITH THE LIVER MEASURING 21.5CM IN GREATEST LENGTH. IT WAS NOTED THAT THERE WERE A FEW NON-OBSTRUCTING CALICEAL CALCIFICATIONS IN THE MID POLES OF BOTH KIDNEYS MEASURING BETWEEN 7MM AND 10MM IN SIZE, SLIGHTLY LARGER ON THE LEFT. THERE WERE A FEW SCATTERED LOW DENSITY LESIONS WITHIN BOTH KIDNEYS , THE LARGEST MEASURES 2CM IN SIZE WITHIN THE MID POLE OF THE LEFT KIDNEY COMPATIBLE WITH SOME BENIGN RENAL CYSTS. SOME MILD MULTICHAMBER CARDIOMEGALY WAS NOTED WITHIN THE CHEST. THE CT OF THE PELVIS REVEALED ABSENCE OF THE UTERUS COMPATIBLE WITH PRIOR HYSTERECTOMY. THE BLADDER AND BOWEL WERE WITHIN NORMAL RANGE. THE INS WAS SEEN WITHIN THE RIGHT LOWER FLANK WITH A WIRE EXTENDING INTO THE RIGHT SACRAL REGION. THE PATIENT HAD A PROCEDURE ON (B)(6) 2014 TO REMOVE THE DEVICE. THE PRE-OP DIAGNOSIS WAS NOTED AS BLADDER PAIN AND BACK PAIN. THE POST-OP DIAGNOSIS WAS NOTED AS BLADDER PAIN, INTERSTITIAL CYSTITIS, BLADDER STONE, STENOTIC URETHRA, BACK PAIN. THE PROCEDURES PERFORMED DURING THE SURGERY INCLUDED CYSTOSCOPY WITH HYDRO DISTENTION, URETHRAL DILATION TO 24 FRENCH, BLADDER STONE REMOVAL, INTERSTIM LEAD AND IPG REMOVAL. IT WAS NOTED THAT THERE WAS A LESS THAN 10ML BLOOD LOSS. SPECIMENS THAT WERE SENT TO PATHOLOGY INCLUDED, CATHETERIZED URINE FOR CYTOLOGY, BLADDER STONE, INS AND LEAD. THE HCP ADMINISTERED A STANDARD PROCEDURE. FINDINGS INCLUDED THE CYSTOSCOPY REVEALED MILD TO MODERATE TRABECULATIONS. THERE WAS A SINGLE BLADDER STONE APPROXIMATELY 2MM. THE URETHRA WAS STENOTIC AND WOULD NOT ALLOW PASSAGE OF THE 22 FRENCH CYSTOSCOPE SHEATH WITHOUT DILATION. THERE WAS TERMINAL BLOODY EFFLUENT AND REFILLING SHOWED GLOMERULATIONS IN ALL FOUR QUADRANTS. THE BLADDER WAS AGAIN DRAINED AND LIDOCAINE UROJET WAS PLACED FOR PATIENT COMFORT. THE HCP THEN MOVED ON TO A STANDARD PROCEDURE FOR THE INS AND LEAD REMOVAL. THE IPG WAS REMOVED WITH NO ABNORMAL ALLEGATIONS. THE LEAD WAS RELEASED FROM THE SURROUNDING SCAR TISSUE, THE SUBCUTANEOUS TISSUE WAS DISSECTED WITH SOME DIFFICULTY TO FIND THE LEAD. THE ENTIRE LEAD AND TINES WERE REMOVED. THE HCP FINISHED THE STANDARD PROCEDURE AND IT WAS NOTED THAT THE PATIENT WAS EXTUBATED IN THE OR AND WENT TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2016 THE FINAL DIAGNOSES WAS PROVIDED BY THE HCP. IT WAS NOTED THAT THE INS AND LEAD AND THE BLADDER STONES WERE SUBMITTED TO PATHOLOGY. ON (B)(6) 2016 LAB RESULTS FOR THE BLADDER STONES NOTED THE 1ST STONE WAS 90% CALCIUM OXALATE MONOHYDRATE. THE SECOND STONE WAS 10% CALCIUM PHOSPHATE (APATITE). THE URINE CYTOLOGY SHOWED SCANTLY CELLULAR SAMPLE, SHOWING FEW IRRITATED INTERMEDIATE UROTHELIAL CELLS IN AN INFLAMMATORY BACKGROUND. NO UROTHELIAL DYSPLASIA OR NEOPLASIA WAS SEEN. PRIOR TO THE EXPLANT, THE PATIENT SENT THE HCP A LETTER. THEY REPORTED THAT SINCE THE INS WAS TURNED OFF, THEIR BLADDER DOES EMPTY; THE ONLY TIME IT IS FULL IS WHEN YOU BEND OVER OR PRESS AGAINST WHAT IS IN THE LOWER PART OF THEIR STOMACH AND THE PAIN WAS SEVERE. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS ENDURING A LOT OF PAIN AND THEY WERE WONDERING ABOUT A SPINAL CORD STIMULATION (SCS) DEVICE TO BE IMPLANTED TO HELP THIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352536 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |