INTERSTIM II
Report
- Report Number
- 3004209178-2013-12404
- Event Type
- Injury
- Date Received
- July 29, 2013
- Report Date
- July 5, 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
- PHYSICIAN
Narratives
(B)(4).
PRODUCT ID: 3093-33, LOT# V142285, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).
(B)(4)
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING NO STIMULATION SENSATION. APPROXIMATELY 2 WEEKS AGO SHE DID NOT FEEL ANY STIM BUT APPROXIMATELY A MONTH TO 6 WEEKS AGO, SHE COULD FEEL STIM. THE PATIENT HAD HAD "AN INCREDIBLE" INCREASE IN HER URINARY SYMPTOMS WHERE SHE USED TO ONLY HAVE TO WEAR A POISE PAD BUT SINCE A MONTH AGO, SHE HAD HAD TO WEAR FULL DEPEND BRIEFS FOR 24 HRS AT A TIME. NO RECENT BODY TRAUMA OR FALLS WERE REPORTED. THE PATIENT HAD RECURRING UTIS (URINARY TRACT INFECTIONS) THAT SHE COULDN'T GET RID OF. THE PATIENT HAD BEEN ON ANTIBIOTICS SINCE (B)(6) 2012 AND WAS TOLD HER BODY WAS NOW RESISTANT TO ANTIBIOTICS. THE PATIENT DID NOT HAVE TYPICAL UTI SYMPTOMS OF FEVER, CHILLS, BLOOD IN HER URINE, ETC. AND ONLY HAD THE FREQUENCY AND URGENCY THAT THEY CAN'T TREAT WITH ANTIBIOTICS. THERE WAS NOTHING MORE THAT COULD BE DONE MEDICALLY FOR HER. A WEEK AGO LAST TUESDAY, THEY INSERTED A PIC LINE BUT NEVER ADMINISTERED ANY DRUGS IN TO THE LINE, SO LAST TUESDAY THE PIC LINE WAS REMOVED. IT WAS CONFIRMED THE INS WAS ON. PROGRAM 2 AT 4.2 WAS CURRENT SETTINGS BUT THE PATIENT DID NOT FEEL ANY STIM. THE PATIENT WAS ASSISTED WITH TRYING ALL OF THE PROGRAMS. PROGRAM 3 AT 3.6 THE PATIENT COULD FEEL STIM BUT IT WAS FELT UP AND TO THE LEFT OF THE PATIENT'S PELVIC FLOOR AREA. PROGRAM 4 THE SETTINGS HAD TO BE TURNED UP TO 8.1 BEFORE THE PATIENT COULD FEEL THE STIM. PROGRAM 1 AT 4.8 THE PATIENT COULD FEEL THE STIM BUT IT WAS IN THE WRONG AREA AGAIN SIMILAR TO PROGRAM 3. THE PATIENT WAS ASSISTED BACK TO THE ORIGINAL PROGRAM 2 AND SETTINGS WERE INCREASED TO 6.1 BEFORE THE PATIENT COULD FEEL THE STIM IN HER PELVIC FLOOR AREA. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOWUP REPORT WILL BE SENT.
FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WORKED UP UNTIL (B)(6) 2013. IT WAS NOTED THAT ALL PROGRAMS WERE TRIED AND THAT THE VOLTAGE WAS INCREASED TO 8 VOLTS BUT HURT THIS HURT THE PATIENT. THE INS WAS TURNED DOWN TO 4/5 BUT THIS DID ¿NOT WORK¿ WORK FOR THE PATIENT. IT WAS ALSO NOTED THAT THE HCP WILL ¿NOT GET WORKING¿ AND THE PATIENT WAS TO UNDERGO BOTOX EVALUATION PER THEIR CHOICE (PATIENT DID NOT WANT TO FIX DEVICE THERAPY). THE HCP CONFIRMED THAT THE PATIENT HAD FREQUENT UTIS AND WAS GETTING PERINEUM CREAM. IN ADDITION, IT WAS NOTED THAT THE PATIENT WAS A ¿VERY COMPLEX CASE¿. NO HOSPITALIZATION WAS REQUIRED FOR THE EVENT AND THE PATIENT OUTCOME WAS REPORTED AS NON-SERIOUS INJURY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE THERAPY ¿WORKED BEAUTIFULLY FOR YEARS,¿ BUT AT THE TIME OF THE CALL THE INTERSTIM ¿DID NOT SEEM TO BE DOING ITS JOB.¿ THE PATIENT CONTINUED TO EXPERIENCED INCONTINENCE AS THEY HAD FOR THE PAST 8 MONTHS. IT WAS NOTED STIMULATION WAS CURRENTLY UP TO 7.5V WHICH WAS NOT A COMFORTABLE SETTING FOR THE PATIENT. AN OVERSTIMULATION SENSATION WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353172 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00063 YR | Required Intervention |