INTERSTIM II
Report
- Report Number
- 3004209178-2016-27434
- Event Type
- Death
- Date Received
- December 29, 2016
- Date of Event
- November 21, 2016
- Report Date
- April 4, 2017
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- UDI-DI
- 00613994913654
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. 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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4).
A PATIENT REPORTED THEY HAVE BEEN HAVING TERRIBLE HEADACHES AND THEIR BLOOD PRESSURE WENT MUCH HIGHER THAN NORMAL, REACHING 196/106. THEY STATED THE ISSUES WERE SUDDEN AND THEY WENT TO THE EMERGENCY ROOM AND URGENT CARE AND HAD X-RAYS CONDUCTED. THEY WERE GIVEN MEDICATION FOR THEIR HIGH BLOOD PRESSURE AND PAIN RELIEVER FOR THE HEADACHES. THEY WERE NOT SURE WHAT WAS CAUSING IT. THE PATIENT ALSO REPORTED THEY WERE NOT SLEEPING WELL. THEY STATED THAT SOMETHING WAS MAKING THEM TIRED SO THEY WOULD SLEEP DURING THE DAY AND NOT AS MUCH AT NIGHT. THEY USED TO SLEEP 7 HOURS PER NIGHT, BUT NOW THEY HAD ONLY BEEN SLEEPING 5 HOURS PER NIGHT. THEY WERE NOT SURE IF IT WAS RELATED TO THE MEDICATION OR NOT. THE PATIENT TURNED THEIR STIMULATION OFF TO SEE IF IT AFFECTS THE SYMPTOMS, BUT HAD ONLY HAD IT OFF FOR 1 TO 1.5 HOURS SO FAR. THEY WERE SCHEDULED TO SEE THEIR NEUROLOGIST TWO WEEK FOLLOWING THE REPORT. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS INDICATED FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION/GASTROINTESTINAL/PELVIC FLOOR.
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED ¿THE PATIENT PASSED AWAY ON (B)(6) 2017 AND I FEAR THE BLADDER DEVICE THAT WAS IMPLANTED IN THEM MAY HAVE CONTRIBUTED TO THEIR DEATH. ABOUT THE MIDDLE OF (B)(6) 2016 THE PATIENT STARTED WITH HEADACHES, OF WHICH THEY NEVER HAD HEADACHES. AFTER SEVERAL TRIPS TO URGENT CARE, THE EMERGENCY ROOM, AND DOCTORS, THEY DISCOVERED HIGH BLOOD PRESSURE, OF WHICH HE NEVER HAD HIGH BLOOD PRESSURE; THEY ALL WANTED TO TREAT HIM WITH PAIN PILLS AND HIGH BLOOD PRESSURE PILLS. EVERY TWO WEEKS, THE PATIENT DONATED PLATELETS TO THE BLOOD BANK, SO HE REGULARLY HAD BLOOD WORK DONE AND THEY ALWAYS CHECKED HIS BLOOD PRESSURE, ALWAYS NORMAL OR BELOW. WE REQUESTED THEY DO AN MRI AND EVEN SUGGESTED IF NEED BE, REMOVE THE BLADDER DEVICE BUT WERE INFORMED BY THE DOCTOR¿S OFFICE THAT AN MRI COULDN¿T BE PERFORMED WITH THE BLADDER DEVICE IN THE BODY. A FEW DAYS LATER ON (B)(6), HE COLLAPSED AT HOME AND WAS RUSHED TO ANOTHER HOSPITAL WHERE WE WERE TOLD HE HAD A SEVERE BRAIN ANEURYSM AND LATER PASSED AWAY. THE SAD PART IS THAT THEY DID DO AN MRI ON THE PATIENT WITH THE IMPLANT IN HIS BODY WHEN THEY WERE RUSHED TO THE HOSPITAL, AND SOMEONE WAS MISINFORMED BY THE MANUFACTURER ABOUT GETTING AN MRI WHICH COULD HAVE COST THE PATIENT HIS LIFE.¿
ADDITIONAL INFORMATION WAS IDENTIFIED WHICH CONFLICTED WITH INFORMATION RECEIVED ON FEBRUARY 17, 2017 FROM THE PATIENT¿S SPOUSE (PREVIOUSLY REPORTED IN MDR FOLLOW-UP #1), REGARDING THE RELATION OF THE PATIENT¿S DEATH TO THE DEVICE. PHONE RECORDS SHOW THAT A HEALTHCARE PROVIDER (HCP) REQUESTED MRI COMPATIBILITY GUIDELINES ON (B)(6) 2016. THE HCP STATED THE PROCEDURE WAS NOT DUE TO A PROBLEM WITH THE DEVICE OR THERAPY, AND NO SYMPTOMS WERE REPORTED. DUE TO THE REQUEST, MRI GUIDELINES WERE SENT REGARDING THE SPECIFIC DEVICE. ON (B)(6) 2016 ANOTHER HCP CALLED STATING THE ¿PATIENT¿S HEALTH HAD DECLINED AND THEY WOULD BE PASSING AWAY VERY SOON,¿ AND THEY WOULD BE ¿PULLING THE BREATHING TUBE IN THE NEAR FUTURE¿ SO THEY WANTED TO DISCUSS THE IMPLANTABLE NEUROSTIMULATOR (INS) AS THE PATIENT WAS GOING TO BE CREMATED. ACCORDING TO THE HCP THE PATIENT¿S DECLINE IN HEALTH WAS NOT RELATED TO THE DEVICE, BUT RATHER A BRAIN BLEED. ON JANUARY 4, 2017 THE PATIENT¿S SPOUSE CALLED AND STATED THE PATIENT PASSED AWAY ON (B)(6) 2017, BUT WHEN THEY WERE ASKED IF THE DEATH WAS THOUGHT TO BE RELATED TO THE DEVICE THEY STATED ¿NO.¿ THE PATIENT¿S SPOUSE ALSO MENTIONED THAT THE PATIENT WAS GOING TO BE CREMATED, AND THAT THEY WOULD REMOVE AND DESTROY THE INS.
ADDITIONAL INFORMATION RECEIVED FROM THE UROLOGIST REPORTED THE PATIENT HAD A HISTORY OF BENIGN PROSTATIC HYPERPLASIA, HYPERTROPHY OF THE PROSTATE WITH URINARY OBSTRUCTION, URINARY URGENCY, DEEP VEIN THROMBOSIS AFTER LEFT FOOT SURGERY IN 1999, AND HYPERLIPIDEMIA. DURING AN OFFICE VISIT WITH THE UROLOGIST ON (B)(6) 2016, THE PATIENT COMPLAINED OF A SIGNIFICANT AMOUNT OF NIGHTTIME URGENCY, SOMETIMES ABOUT 4 TO 6 TIMES A NIGHT, ALTHOUGH THEY WEREN¿T DRINKING BEFORE GOING TO BED. IT WAS NOTED THE PATIENT WAS TAKING ONE 81 MG ASPIRIN DAILY, ONE ZOCOR 20 MG TABLET DAILY, AND ONE CAPSULE OF TAMSULOSIN ER 04. MG. DURING THIS VISIT THE PATIENT WAS DOCUMENTED AS NEVER BEING A SMOKER AND THE PATIENT¿S FAMILY HISTORY NOTING ONE OF THEIR SISTERS DIED OF A BRAIN ANEURYSM AT THE AGE OF 42. THE PLAN AT THE END OF THIS VISIT WAS TO TRY VESICARE 5 MG IN THE EVENING AND FOLLOW-UP IN 4 WEEKS FOR TOLERABILITY AND EFFICACY ALONG WITH A POSTVOID RESIDUAL. ON (B)(6) 2016 THE PATIENT WAS SEEN AT THE UROLOGISTS OFFICE FOR FOLLOW-UP ON NOCTURIA. AFTER STARTING VESICARE ¿THE PATIENT HAD SIGNIFICANT IMPROVEMENT WITH A POSTVOID RESIDUAL OF 18 ML, AND WAS ABLE TO SLEEP ABOUT 5 HOURS WITH A LITTLE DIFFICULTY GOING BACK TO BED, BUT IT WAS MUCH IMPROVED.¿ ON (B)(6) 2016 THE PATIENT WAS SEEN BY A GENERAL PRACTITIONER FOR FOLLOW-UP ON AN MRI REGARDING PAIN WITH SITTING, WALKING, AND CERTAIN MOVEMENTS. THE PATIENT¿S BLOOD PRESSURE AT THAT TIME WAS 157/78, HEART RATE 87, TEMPERATURE 99.4, O2 SATS 96%, AND A BMI OF 28.92. ON (B)(6) 2016 THE PATIENT HAD AN OFFICE VISIT WITH THE UROLOGIST WHERE THEIR BLOOD PRESSURE WAS 120/65 WITH A HEART RATE OF 86. DURING THIS TIME THE PATIENT COMPLAINED OF VERY BOTHERSOME NIGHTTIME URGENCY AND FREQUENCY WITH FOUR EPISODES A NIGHT. AT THIS TIME, THE PATIENT DECIDED THEY WANTED TO PROCEED WITH OTHER OPTI ONS FOR THEIR NIGHTTIME FREQUENCY AND URGENCY AND CHOSE TO ¿PROCEED WITH PERIPHERAL NERVE EVALUATION IN LIEU OF FULL URINARY NEUROMODULATION.¿ ON (B)(6) 2016 THE PATIENT WAS SEEN BY THEIR GENERAL PRACTITIONER FOR PRE-OPERATIVE CLEARANCE. THE PHYSICIAN NOTED THE PATIENT WAS POSITIVE FOR JOINT PAIN AND URINARY FREQUENCY, BUT WAS NEGATIVE FOR ANY OTHER SYMPTOMS INCLUDING: CHEST PAIN, IRREGULAR HEARTBEAT/ PALPITATIONS, CLAUDICATION, AND EDEMA. A PHYSICAL ASSESSMENT ALSO SHOWED THE PATIENT¿S HEART RATE WAS A REGULAR RATE AND RHYTHM WITH NO MURMURS, GALLOPS, OR RUBS. THE PATIENT¿S BLOOD PRESSURE AT THIS TIME WAS 160/84, HEART RATE 75, TEMPERATURE 98.3, O2 SATS OF 97% ON ROOM AIR, AND A BMI OF 29.07. FOLLOWING THIS THE PATIENT WAS CLEARED FOR URINARY SURGERY. ON AUGUST 29, 2016 THE PATIENT WAS SEEN IN THE UROLOGY CLINIC FOR FOLLOW-UP ON THEIR URINARY THERAPY WHERE THE PHYSICIAN¿S NOTES STATED ¿THE PATIENT UNDERWENT PERIPHERAL NERVE EVALUATION ON AUGUST 26, 2016 WHERE THEY ONLY WOKE UP 1 OR 2 TIMES AT NIGHT AND WERE DOING QUITE WELL WITH IT.¿ AN OFFICE VISIT WITH THE UROLOGIST ON (B)(6) 2016 STATED THE PATIENT ¿HAD INTRACTABLE NOCTURIA X5 AT NIGHT AND UNDERWENT URINARY NEUROMODULATION IMPLANTATION ON (B)(6) 2016. THE INCISION SITE WAS HEALING WELL FROM THE GENERATOR SITE, BUT THE PATIENT WAS STILL LEARNING HOW TO MANAGE THE GENERATOR IN TERMS OF REALIZING THERE WERE DIFFERENT PROGRAMS THAT COULD FINE TUNE THEIR TREATMENT OUTCOME.¿ THE PHYSICIAN WAS HAVING THE MANUFACTURER¿S REPRESENTATIVE (REP) COME IN ONCE A MONTH WITH THE NEXT APPOINTMENT SCHEDULED FOR OCTOBER TO REEDUCATE THE PATIENT AND HELP WITH THEIR SYMPTOMS. ON (B)(6) 2016 THE PATIENT WAS SEEN BY THEIR GENERAL PRACTITIONER FOR FOLLOW-UP AFTER BEING SEEN BY URGENT CARE FOR HEADACHES AND SUDDEN SHARP PAIN ACROSS THE OCCIPITAL AREA WHICH THEY ¿THOUGHT FOR A MOMENT WAS A STROKE,¿ BUT THE WORK-UP BY URGENT CARE SHOWED THIS WAS NEGATIVE. DURING THE OFFICE VISIT THE HCP STATED ¿THE PATIENT WAS BETTER AFTER COMMON ANALGESICS.¿ IT WAS FURTHER NOTED THE ¿PATIENT HAD NO TROUBLE WITH SPEECH NOR COORDINATION, BUT LATER DURING BOWEL MOVEMENT STRAINING TRIGGERED THE SAME SHARP FEELING IN THE OCCIPITAL AREA.¿ A CT AND CERVICAL FILM WERE REVIEWED AND ACCORDING TO THE HCP ¿IF AN MRI WAS CONSIDERED¿ THEY WOULD ¿NEED TO CHECK IF IT WAS POSSIBLE TO HAVE AN MRI.¿ VITAL SIGNS WERE CHECKED AT THIS TIME WITH THE PATIENT¿S BLOOD PRESSURE BEING 158/80, HEART RATE 69, TEMPERATURE 98.9, O2 SATS 98%, AND A BMI OF 28.47. AT THE CONCLUSION OF THE VISIT THE HCP ORDERED AN MRI OF THE CERVICAL NECK. ON (B)(6) 2016 THE PATIENT WAS SEEN BY THEIR GENERAL PRACTITIONER FOR FOLLOW-UP AFTER BEING SEEN IN THE EMERGENCY ROOM AFTER A WEEK OF CONSTANT OCCIPITAL HEADACHES WITH TINNITUS IN BOTH EARS WHERE THEY WERE FOUND TO HAVE HIGH BLOOD PRESSURE. DURING THE EMERGENCY ROOM VISIT THE PATIENT HAD A HEAD CT PERFORMED WITH ¿NO ACUTE FINDINGS.¿ DURING THE OFFICE VISIT THE PATIENT¿S BLOOD PRESSURE WAS 131/74, HEART RATE 68, O2 SATS 98%, AND A BMI OF 28.47. AT THE CONCLUSION OF THIS VISIT, THE HCP DIAGNOSED THE PATIENT WITH PRIMARY HYPERTENSION AND INSTRUCTED THEM TO KEEP A ¿TORADOL BLOOD PRESSURE DIARY.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 862753 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 | 00613994913654 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death |