INTERSTIM II
Report
- Report Number
- 3004209178-2014-12709
- Event Type
- Injury
- Date Received
- July 9, 2014
- Report Date
- June 17, 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
- PA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT # VA0GZHU, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).
IT WAS REPORTED THAT THE PATIENT FELT NO OR VERY SLIGHT STIMULATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SINCE IMPLANTATION. THE PATIENT STATED THAT OVER THE LAST 3-4 DAYS THEY HAVE HAD A RETURN OF THEIR SYMPTOMS. THE PATIENT WAS IMPLANTED ON MAY 12 AND THAT THEY WENT BACK TO THEIR DOCTOR EXACTLY 2 WEEKS LATER (WHICH WAS ¿POSSIBLY THE (B)(6)¿) AT WHICH TIME THEY WENT OVER THE PROGRAMMER UNIT WITH THE PATIENT. THE PATIENT STATED THAT THEY ¿DIDN¿T PLAY WITH IT¿ AND DOESN¿T REMEMBER HOW TO USE THE PROGRAMMER. THE PATIENT REQUESTED ASSISTANCE WITH THE USE OF THE PROGRAMMER AND HAD CALLED THEIR DOCTOR WHO DIRECTED THEM TO CONTACT THE MANUFACTURER¿S REPRESENTATIVE FOR DIRECTION. IT WAS NOTED THAT THE PATIENT DID NOT HAVE THE PROGRAMMER UNIT WITH THEM (THEY WERE AT WORK) AND WAS GOING TO REPORT BACK TONIGHT OR TOMORROW MORNING WHEN THEY HAVE IT WITH THEM. ADDITIONAL INFORMATION RECEIVED 6 DAYS LATER REPORTED THAT FOR THE FIRST 2 WEEKS AFTER IMPLANTATION, THE THERAPY WORKED PERFECTLY BUT AFTER THAT ¿EVERYTHING CHANGED¿ AND THE PATIENT WAS ¿NOT SURE WHAT HAPPENED. IT WAS ALSO REPORTED THAT THE AREA OF THE IMPLANT WAS SENSITIVE TO THE TOUCH. THE PATIENT STATED THAT THE INS HAD ¿ROLLED¿ AND THAT THEIR HEALTHCARE PROFESSIONAL (HCP) ¿FLATTEN IT OUT¿ WHEN THEY WENT BACK FOR THEIR CHECK-UP 2 WEEKS AFTER. IT WAS NOTED THAT WHEN THE PATIENT WOULD LIE DOWN OR SITTING IN A CHAIR OR SLOUCHING IT HURTS AND ¿THAT¿S WHEN IT FEELS LIKE A JOLT¿. THE PATIENT STATED THAT THEY THOUGHT THE INS SHOULD BE FLAT BUT IT IS UNCOMFORTABLE AND IN THE SHAPE ¿OF A SAUSAGE/LONG ROLL¿ AND THAT IT WAS ¿INDENTED¿ AND MOVING ¿LIKE A BLISTER/BUBBLE STICKING OUT¿. THE PATIENT REITERATED THAT THE DEVICE WAS ¿MOVING/ROLLING¿. IN ADDITION, IT WAS REPORTED THAT THEY COULD NOT GET THE ¿WIRE¿ INTO THE SACRAL NERVE AND THAT THE PATIENT ¿DID NOT KNOW WHERE THE WIRE IS LOCATED¿. THE PATIENT ALSO STATED THAT IF THEY DON¿T FEEL ANYTHING AND HOW WERE THEY TO KNOW IF IT¿S WORKING OR NO (PATIENT WAS DIRECTED TO CALL THE MANUFACTURER BY THEIR HCP). THE PATIENT STATED THAT THEIR HCP TOLD THEM THAT THEY MAY NOT BE FEELING THE STIMULATION AFTER A WHILE. THE PATIENT WAS ABLE TO SYNCHRONIZE WITH THEIR INS WHERE IT WAS DETERMINED THEY WERE ON PROGRAM 3 AT 2.9 VOLTS AND WAS ABLE TO INCREASE TO 3.1 VOLTS BUT DID NOT FEEL THE STIMULATION. THE PATIENT LATER STATED THAT THEY FELT SOMETHING AT THE BOTTOM OF THEIR REAR BUT IT WAS NOT A TINGLING SENSATION. IT WAS NOTED THAT THE PATIENT WAS IMPLANTED WITH THE DEVICE FOR BOWEL INCONTINENCE AND THAT THE SYMPTOMS HAD RETURNED SUDDENLY. THERE WERE NO REPORTED FALLS OR TRAUMA ASSOCIATED WITH THE EVENT. THE PATIENT STATED THAT THEY HAD NOT USED THE PROGRAMMER SINCE THE MANUFACTURER¿S REPRESENTATIVE SET IT UP SHORTLY AFTER IMPLANTATION. IT WAS CONFIRMED THAT THERE WERE BATTERIES IN THE PROGRAMMER UNIT. THE PATIENT WAS GOING TO ¿PLAY AROUND WITH THE SETTING¿. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S INS HAD MOVED AND THEY WANTED TO KNOW IF ANY OTHER PATIENTS HAD HAD THAT HAPPEN AND WHAT THEY DID TO RESOLVE IT. THE INS WAS DOWN IN THE PATIENT'S BOTTOM AND THEY WERE SITTING ON IT. THE PATIENT'S HCP WAS GOING TO PUT IT BACK WHERE IT SHOULD BE BECAUSE THE INS FELL OUT OF THE POCKET AND WAS CLOSE TO THE BOTTOM OF THEIR REAR END. LITTLE BY LITTLE IT CHANGED 2 WEEKS AFTER IMPLANT AND THE DEVICE ROLLED UP LIKE A SAUSAGE AND THEY HAD TO PUSH IT DOWN. IT WAS NOTED THAT THE PATIENT LOST 20 TO 30 POUNDS IN (B)(6), WHICH WAS BEFORE THE IMPLANT. THE PATIENT ALSO HAD BLADDER PROBLEMS AND WHEN THEY GOT THEIR DEVICE THEIR FECAL ISSUE WAS WORSE THAN THEIR BLADDER ISSUE. NOW THE PATIENT'S BLADDER PROBLEM WAS JUST AS BAD, IF NOT WORSE THAN THEIR FECAL ISSUES AND THIS STARTED ABOUT 2 MONTHS AGO, MAYBE LONGER. THE PATIENT HAD TO WEAR DEPENDS AND COULDN'T ALWAYS MAKE IT TO THE BATHROOM.
T WAS REPORTED THAT SINCE IMPLANTATION OF THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS), THERE WAS A "THING ROLLING AROUND AND MOVING UNDER HER SKIN BY THE CRACK OF HER BUTT." THE PATIENT STATED THAT IT FELT LIKE "A SAUSAGE OR A PENCIL" BUT THAT IT HAD GOTTEN BETTER OR THAT THEY HAD GOTTEN USED TO IT. 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 HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2014. THE PATIENT SAW HER UROLOGIST FOR A RETURN VISIT "YESTERDAY." THE UROLOGIST LOOKED AT A "ROLL-SHAPED BUMP" UNDER A DIMPLE ON BUTTOCKS. THE HCP REPORTEDLY STATED THAT IMPLANTABLE NEUROSTIMULATOR (INS) NEEDED TO BE REMOVED. THE PATIENT INFORMED THE UROLOGIST OF HER APPOINTMENT WITH THE COLORECTAL SURGERY CLINIC ON (B)(6) 2014. IT WAS STATED THAT THE PATIENT SHOULD HAVE BEEN TOLD THAT "ROLLING" COULD TAKE PLACE SO SHE COULD HAVE KNOWN WHAT TO DO BEFORE NOW. IT WAS ALSO STATED THAT THE PATIENT'S BOWEL ISSUES RETURNED AFTER BEING NORMAL FOR 2 WEEKS. THE PATIENT WAS ALSO TOLD DURING THE RETURN VISIT THAT NOT FEELING ANYTHING WAS NORMAL. THE PATIENT NEVER FELT ANYTHING AFTER THE SECOND PROCEDURE (INTERPRETED AS PERMANENT IMPLANT AFTER ADVANCED TRIAL). IT WAS LATER REPORTED THAT THE INS FLIPPED IN THE POCKET. THE ISSUE WAS STATED TO NOT BE DEVICE RELATED AND THERE WAS NO REPROGRAMMING NEEDED. IT WAS STATED THAT THE "INTENSITY" (AMPLITUDE) WAS INCREASED AND THE PATIENT WAS RE-INSTRUCTED ON USE OF THE PROGRAMMER. THE PATIENT HAD 50% OR GREATER SYMPTOM REDUCTION. IT WAS NOTED THAT REPOSITIONING OF THE INS WAS PLANNED. THE EVENT WAS CONSIDERED ONGOING AND WOULD BE REASSESSED IN TWO WEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400589 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Required Intervention |