INTERSTIM II
Report
- Report Number
- 3004209178-2012-09774
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Report Date
- October 3, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V526889, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
(B)(4).
IT WAS REPORTED THE PATIENT DID NOT HAVE CONCERNS REGARDING THEIR DEVICE OR THERAPY. THERAPY HAD NOT BEEN EFFECTIVE FOR THEIR INCONTINENCE. EXPLANT WAS TO BE FOLLOWED BY A MRI.
IT WAS REPORTED THE PATIENT¿S STIMULATOR WAS REMOVED DUE TO AN EXPIRED BATTERY. THE BATTERY HAD EXPIRED TWO YEARS AND TWO MONTHS PRIOR TO CALL. IT HAD STOPPED OPERATING. FOLLOWING EXPLANT, THE PATIENT BLED THROUGH THE INCISION; THE POCKET HAD FILLED WITH BLOOD. THE PATIENT WAS STILL BLEEDING A LITTLE.
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD CONCERNS THAT THE DEVICE MAY HAVE BEEN DAMAGED WHEN HE FELL DIRECTLY ON THE DEVICE. IT WAS STATED THAT HE HAS RECEIVED ASSISTANCE FROM HIS DOCTOR OR MEDTRONIC REPRESENTATIVE AND HIS CONCERNS WERE RESOLVED. THE PATIENT WAS BEING MONITORED DAILY AT THE TIME OF REPORT. HIS LATEST APPOINTMENT WITH HIS PHYSICIAN WAS (B)(6) AND HE REPORTED THAT HE HAD NO SCHEDULED APPOINTMENTS AT THE TIME. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
IT WAS REPORTED THAT THE PATIENT COULD NOT SENSE THE "VIBRATION" AND A LOSS OF THERAPEUTIC EFFECT; THERE WAS A "50% REDUCTION" IN SYMPTOMS WHEN THE DEVICE WAS FIRST IMPLANTED, BUT THE PATIENT NOTICED LESS SYMPTOM REDUCTION 6 MONTHS TO A YEAR PRIOR TO THIS REPORT. IT WAS STATED THAT THE PATIENT "PASSED MORE," HAD AN INCREASED "NEED TO GO," URINATED "MORE" SINCE IMPLANT, WORE PADS TWICE A DAY, AND WAS "WETTER" WITHIN THE "PAST 6 MONTHS." IT WAS ALSO NOTED THAT THE PATIENT HAD PAIN PROBLEM IN HIS BACK AND HAD PROSTATE CANCER. THE PATIENT PROGRAMMER WAS DESCRIBED AS "FLASHING," BUT THE PATIENT USED IT A WEEK AGO AND CHANGED THE BATTERIES ON THE MORNING OF THE REPORT. IT WAS STATED THAT THE PROGRAMMER SHOWED 4 VOLTS AT 5.1 VOLTS. IT WAS NOTED THAT THE PATIENT WAS UNCOMFORTABLE AND COULD NOT SLEEP AT 5.1 VOLTS "AROUND IMPLANT DATE", BUT DID NOT FEEL UNCOMFORTABLE ANYMORE AT 5.1 VOLTS "FOR THE PAST 2 MONTHS" AND WANTED TO INCREASE STIMULATION. THE PATIENT FELL "ABOUT 6 MONTHS" PRIOR TO THE REPORT DATE. THE DOCTOR WANTED TO DO AN MRI, BUT WILL WAIT FOR TWO MONTHS FOR LUPRON CYCLE. A FEW DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS HAVING BACK PAIN AND ASKED HIS ONCOLOGIST ABOUT AN MRI FOR HIS BACK PAIN TO DETERMINE IF HE HAD A HERNIATED DISC OR NERVE PROBLEM. IT WAS NOTED THAT THE PATIENT ADJUSTED HIS STIMULATION BECAUSE OF HIS BOWEL MOVEMENT. IT WAS LATER REPORTED THAT THE PATIENT "DID NOT FEEL ANY STIMULATION" AND HAD AN INJURY. THE PATIENT REPORTEDLY FELL AND HIT HIS BACK AGAINST THE BASE OF THE SHOWER; THE PATIENT NOTICED BRUISING AROUND THE IMPLANT AREA AND PAIN IN THE POCKET AREA. IT WAS ALSO NOTED THAT THE PATIENT STILL URINATED "QUITE A BIT," DECREASED STIMULATION BACK TO 5.1 VOLTS BECAUSE IT WAS "IRRITATING," AND COULD NOT MAKE ADJUSTMENTS WITH OR WITHOUT ANTENNA ATTACHED. IT WAS STATED THAT THERE WERE COMMUNICATION ISSUES AND TROUBLESHOOTING WAS LIMITED DUE TO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MDT PUERTO RICO OPERATIONS CO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |