INTERSTIM II
Report
- Report Number
- 3004209178-2014-12468
- Event Type
- Injury
- Date Received
- July 2, 2014
- Report Date
- June 10, 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
- PA, US
- Reporter Occupation
- OTHER
Narratives
CORRECTION: IT WAS PREVIOUSLY REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT LOCATED IN THE RIGHT BUTT CHEEK. HOWEVER, THE INITIAL REPORTER INDICATED THAT THE INS WAS LOCATED IN THE RIGHT BUTT CHEEK. (B)(4).
(B)(4) NO LONGER APPLIES TO THIS EVENT.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT# VA09E61, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).
(B)(4).
INFORMATION RECEIVED LATER INDICATED THAT PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THE HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE. THE PATIENT APPOINTMENT WAS SCHEDULED FOR WEEKLY BASIS.
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT SHE HAD INTERSTITIAL CYSTITIS AND HAD THE DEVICE IMPLANTED TO HELP WITH RETENTION. THE DEVICE WAS GIVING HER GREATER THAN 50 PERCENT REDUCTION OF SYMPTOMS AT FIRST, BUT THEN HER BLADDER RUPTURED IN 2014. HER DOCTOR DID OBLATION OF HUNNER'S ULCERS AND THEY FELT THIS MAY HAVE CAUSED THE BLADDER RUPTURE. FOLLOWING BLADDER RUPTURE, HER THERAPY WAS NOT AS EFFECTIVE AND SHE STARTED LEAKING AGAIN. SHE HAD CERVICAL FUSION DONE IN (B)(6) 2015 FOLLOWING THE BLADDER RUPTURE AND SINCE THEN, SHE HAD A GREATER LOSS OF THERAPEUTIC BENEFIT, HER SYMPTOMS OF LEAKING HAD WORSENED, AND SHE WAS SELF-CATHETERIZING TWO TO THREE TIMES A DAY. THE LAST TIME THE PATIENT WENT TO HER HEALTHCARE PROVIDER'S OFFICE FOR REPROGRAMMING IN (B)(6) 2016, THEY TOLD HER THAT THE MAIN LEAD ELECTRODE WAS NO LONGER WORKING. SHE WONDERED IF THIS WAS SAFE OR NOT. A NURSE PRACTITIONER REPROGRAMMED THE DEVICE AROUND THE NON-FUNCTIONING ELECTRODE, BUT THE PATIENT WAS STILL NOT HAVING THERAPEUTIC BENEFIT. THE HEALTHCARE PROVIDER'S OFFICE INSTRUCTED HER NOT TO CHANGE PROGRAMS, BUT TOLD HER THAT SHE COULD TURN STIMULATION UP OR DOWN AS SHE FELT NECESSARY. THE PATIENT SAID SHE MAY HAVE TO CONSIDER REMOVING THE DEVICE IF IT WAS NO LONGER GOING TO HELP HER, BUT SHE DIDN'T WANT TO. NO POTENTIAL EVENT CAUSE, DIAGNOSTICS, INTERVENTIONS, OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION FROM THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT'S UNCLERS, BLADDER RUPTURE AND CERVICAL FUSION WERE NOT RELATED TO THE DEVICE OR THERAPY. THE PULSE WIDTH AND AMPLITUDE WERE RE-RUN; LEAD 0 WAS STILL NON-FUNCTIONING WITH CONTACTS 1, 2 AND 3. THE DEVICE WAS REPROGRAMMED WITHOUT 0. THE PATIENT HAD URINARY LEAKAGE PRIOR TO THE NON-FUNCTIONING ELECTRODE. THE URINARY LEAKAGE BEGAN IN (B)(6) 2014 WITH USE OF MEDICATIONS, THEY FOUND PROGRAM TO PROVIDE IMPROVEMENT. THERE WAS AN INCREASE OF URINARY LEAKAGE IN (B)(6) 2015, THEY FOUND THE NON-FUNCTIONING ELECTRODE. THE DEVICE WAS REPROGRAMMED AND THE HCP SPOKE TO THE PATIENT TWICE AND THERE WERE NO COMPLAINTS. THE HCP WAS UNSURE WHAT THE CAUSE OF THE ELECTRODE FAILURE WAS. THE PATIENT WAS SEE IN THE OFFICE BY THE HCP. THE FOUND A PROGRAM AND THE PATIENT WAS FEELING STIM IN THE PERINEUM. SHE WAS TO RETURN 2 WEEKS AFTER THE REPORT WITH A MANUFACTURERS'S REPRESENTATIVE.
IT WAS REPORTED THE PATIENT HAD PAIN AT THE IMPLANT SITE SINCE IMPLANT. THE PATIENT¿S PRE-EXISTING BACK INJURY WAS BEING IRRITATED BY THE DEVICE. X-RAYS SHOWED THAT THE IMPLANT LOOKED GOOD AND HAD NOT MIGRATED.
IT WAS INDICATED THAT THE PATIENT HAD 2 BAD FALLS IN (B)(6) 2014, AND SHE HIT THE IMPLANT BATTERY. IT WAS NOTED THAT PATIENT HAD A LOT OF PAIN ON THE RIGHT SIDE IN THE PELVIC AREA. IT WAS INDICATED THAT NEUROSTIMULATOR WAS NOT LOCATED ON THE RIGHT BUTT CHEEK. IT WAS INDICATED THAT PATIENT THE HEALTH CARE PROVIDER (HCP) COULD NOT IMPLANT THE DEVICE DOWN AS FAR AS HE WOULD LIKE DUE TO PATIENT¿S BODY STRUCTURE. IT WAS INDICATED THAT PATIENT WAS NOT SURE IF IMPLANT HAD MOVED. IT WAS INDICATED THAT HCP STATED THAT THE PAIN COULD BE FROM PREVIOUS INJURY IN HER SPINE, BUT PATIENT COULD TELL THE DIFFERENCE, SHE WAS THINKING IT WAS FROM THE IMPLANT AREA. IT WAS REPORTED THAT THE IMPLANT INITIALLY HELPED HER, BUT SHE COULD NOT TELL NOW IF IT WAS HELPING BECAUSE SHE HAD "INSTALLATIONS" TWICE A WEEK, WHERE FLUID WAS INJECTED INTO HER BLADDER, AND SHE WAS TAKING ATARACS AND ANATRIPLINE. IT WAS NOTED THAT THE PATIENT COULD POTENTIALLY GO DOWN TO ONE INSTALLATION A WEEK. IT WAS INDICATED THAT PATIENT HAD HYDRO BLADDER EXTENSION TWICE IN (B)(6). THE PATIENT HAD BLADDER PROCEDURE AND THE HCP FOUND A LOT OF ULCERS AND HE DID SOME BURNING. THE PATIENT WAS IMPLANTED FOR IC AND INCONTINENCE. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 388563 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00043 YR | Required Intervention |