SYNCHROMED II
Report
- Report Number
- 3004209178-2013-04789
- Event Type
- Injury
- Date Received
- July 3, 2013
- Date of Event
- July 16, 2012
- Report Date
- July 19, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- 860004
- Removal / Correction Number
- Z-0497-2013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, LOT # N183229002, IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, LOT # N183229002, IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).
(B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED HAVING SEVERAL PROBLEMS. THE PATIENT NOTED DISSATISFACTION WITH THE PUMP MANAGEMENT HEALTH CARE PROVIDER (HCP) AND INDICATED IN (B)(6) 2012, THE HCP FIRST DIAGNOSED THE PATIENT WITH SEVERAL PROBLEMS WHICH THE PATIENT WOULD NEED THE PUMP FOR, BUT PER THE PATIENT THEY SUBSEQUENTLY FOUND OUT HAVING ¿NONE OF IT¿. PER THE PATIENT, THE DIAGNOSIS GIVEN BY THE HCP INCLUDED SCOLIOSIS, OSTEOPOROSIS, SCIATICA AND DEGENERATED DISC DISEASE . THE PATIENT THEN STATED ¿THE ONLY THING I DO HAVE IS A MILD DEGENERATED DISC DISEASE, BUT NOTED THEY DID NOT HAVE SCOLIOSIS OR SCIATICA. THE PATIENT STATED ¿I HAVE OSTEO-PEDIA, MILD DEGENERATED DISC DISEASE AND AGE RELATED TERRIBLE POSTURE¿. THE PATIENT DID STATE THOUGH THERE WERE PAIN ISSUES FOR PUMP USE INDICATIONS, BUT LATER STATED ¿I GUESS HE (HCP) WANTED MONEY AND HE DID THAT WITH THE PAIN PUMP. THE PATIENT SUBSEQUENTLY LOST HER INSURANCE AND COULD ¿NOT AFFORD IT ANYMORE¿. THE PATIENT THEN STATED ¿IT WOULD GET TO THE POINT 8-9 MONTHS WOULD GO BY, A YEAR, FOR TWO YEARS, NO A YEAR, 8 MONTHS PASSED BEFORE I SAW HIM AGAIN". THE PATIENT INDICATED BEING TOLD THAT LENGTH OF TIME WAS TOO LONG TO GO WITHOUT HAVING ¿IT CHECKED OUT¿. IT WAS AT THAT TIME THE PATIENT DECIDED THEY WANTED THE PUMP REMOVED. THE PATIENT STATED ¿LITTLE DID I KNOW IN (B)(6) 2012 THAT THE PUMP WAS DEFECTIVE¿. THE STATEMENT WAS MADE IN REFERENCE TO THE PUMP ALARM. AS PREVIOUSLY REPORTED, THE ALARM HAD GONE OFF, AND THE PATIENT DIDN'T HEAR IT, AND THE PATIENT BELIEVED IT DIDN'T GO OFF, AS IT WAS ¿DEFECTIVE¿. THE ALARM DID NOT SOUND WHEN PER THE PATIENT, THE PUMP WAS EMPTY. THE PATIENT LOOKED OUT PRINT OUT, IT HAD ON THERE THAT THE ALARM HAD GONE OFF. PT WAS FEELING PRETTY GOOD AT THAT TIME. PATIENT INDICATED BECAUSE SHE DIDN¿T HEAR THE ALARM, SHE WASN¿T SURE THE BATTERY WORKED, ALTHOUGH THE SHELF LIFE WAS 6-7 YEARS, AND THE HCP SAID TO THE PATIENT ¿THE PUMP WAS IN FOR LIFE¿. PER THE PREVIOUSLY REPORTED INFORMATION THAT THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS AT THE TIME OF THE PUMP ALARM NOT BEING HEARD, IT WAS UNCLEAR THE EXACT TIMELINE OF EVENTS. THE PATIENT FURTHER DESCRIBED AN UNRELATED PROCEDURE SHE UNDERWENT IN (B)(6) 2012 FOR RECTOCELE REPAIR, AND THE PUMP AT THAT TIME WAS AT 0.075 CONTINUOUS, PER THE HCP WHEN SHE WAS IN THE HOSPITAL. THE PATIENT STATED THAT ¿WHENEVER YOU HAVE SURGERY AND YOU HAVE A PAIN PUMP THEY ARE GOING TO GIVE YOU MORPHINE BECAUSE OF THE PAIN PUMP¿, AND THAT SHE DID NOT NOTIFY THE PUMP MANAGEMENT HCP ABOUT THE SURGERY, AS ¿THIS IS A FEMALE PROBLEM¿. PATIENT INDICATED THAT ALTHOUGH THE HOSPITAL KNEW SHE HAD A PAIN PUMP, THE PATIENT OVERDOSED AND HAD TERRIBLE EXPERIENCE. THE PATIENT THEN REPORTED ON (B)(6), SHE WENT TO SEE THE PUMP HCP AFTER TRYING TO REACH HIM FOR A WEEK, AND THE PATIENT WAS OVERDOSING. PER THE PATIENT HER BLOOD PRESSURE WAS 210/120. THE PATIENT AGAIN STATED SHE KNEW THE PUMP WAS DEFECTIVE. THE PUMP WAS ALSO ULCERATED OUT OF THE POCKET (SEE MANUFACTURING REPORT # 3004209178-2011-09286) AND THE HCP TOLD THE PATIENT TO WEAR A GIRDLE, BUT THE PATIENT WAS TOLD BY ANOTHER TO ¿NOT DO THAT¿. THE PATIENT THEN INDICATED THAT THEY SAID THAT SHE COULD HAVE THE PUMP REMOVED ON THE FOLLOWING DAY OF (B)(6) 2013, BUT THE PATIENT DID NOT WANT TO DO THAT, AS HER BLOOD PRESSURE WAS HIGH, SHE JUST HAD SURGERY ON THE (B)(6) WHICH WAS ONLY 13 DAYS EARLIER AND THE PATIENT DID NOT WANT TO BE PUT ON DRUGS. THE PATIENT WANTS TO LOWER IT AND THEN REMOVE IT, BUT THE PATIENT INDICATED THERE WAS A PROBLEM AS SHE DID NOT HAVE INSURANCE AND SHE DIDN¿T FEEL IT WAS HER RESPONSIBILITY BECAUSE THE ¿PUMP IS BAD¿. THE ENTIRE TIME THE PATIENT WAS TALKING TO THE HCP ON (B)(6), SHE SAID ¿WHILE I AM TALKING TO HIM I AM OVERDOSING¿. IT WAS WHEN SHE TOLD THE HCP SHE WAS OVERDOSING, HE SAID HE WANTED TO TAKE THE PUMP OUT THE NEXT DAY, BUT THE PATIENT SHE DIDN¿T WANT TO FOR PREVIOUSLY STATED REASONS. THE HCP ALSO GAVE THE PATIENT THE OPTION OF GOING ON ORAL MEDICATION INSTEAD, BUT THE PATIENT REFUSED. THE PATIENT THEN STATED WHEN SHE CONFRONTED THE DR. ABOUT THE ALARM AND SYMPTOMS ISSUES IN MAY AND JULY, THE DR ORDERED THE PATIENT TO LEAVE THE OFFICE, AND THE PATIENT WAS SUBSEQUENTLY EXCUSED FROM THE HCP¿S SERVICE FOR ¿BEING ON DRUGS¿, BUT PER THE PATIENT THE DRUGS WOULD HAVE BEEN FROM THE SURGERY SHE HAD 13 DAYS EARLIER. THE PATIENT REPORTED THAT SHE WENT AROUND AND RETRIEVED ALL HER MEDICAL RECORDS, AND THE NOTES FROM THE LAST OFFICE VISIT, THE HCP WAS ¿LYING¿. PER THE PATIENT, THE HCP HAD NOT LOOKED AT THE PUMP SINCE (B)(6) OF 2012 WHEN SHE WANTED IT TURNED DOWN. THE PATIENT FURTHER WENT ON TO REPORT SYMPTOMS OF BURNING, TWISTING, SUN BURN, PAIN UP BACK, WHOOSHING FEELING AND DIFFICULTY BREATHING. THE PATIENT AGAIN REITERATED BEING VERY UPSET WITH THE HCP AND THINKS THE HCP IS JUST UPSET WITH HER BECAUSE SHE ¿CALLED HIM OUT¿, AS IN (B)(6) 2012 THE PATIENT HAD A REFILL AND WHEN GOING BACK IN (B)(6) IS WHEN ¿EVERYTHING HIT THE FAN WHEN HE LOWERED IT¿. THE PATIENT THEN STATED SHE BELIEVED THERE WAS STILL DRUG IN THE PUMP, AND THAT SHE HAS GAINED ASSISTANCE FROM ANOTHER HEALTH PROFESSIONAL TO POSSIBLY LOOK FOR A NEW DR. IN A YEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
IT WAS REPORTED THAT IN (B)(6) 2012 THE PATIENT LAST SAW THE PHYSICIAN. AT THAT POINT THE PATIENT¿S PAIN WAS AT ZERO AND THE PATIENT WANTED TO SLOWLY DECREASE THE DOSAGE IN THE PUMP SO SHE DIDN¿T GO THROUGH WITHDRAWAL. INSTEAD THE PHYSICIAN INCREASED THE DOSE BY 35% WITHOUT THE PATIENT¿S KNOWLEDGE AND GAVE HER A BOLUS ¿BECAUSE THE PUMP HAD BEEN EMPTY.¿ IT WAS NOTED THAT THERE WAS A LOW RESERVOIR NOTED AT THAT VISIT, BUT THE PATIENT NEVER HEARD AN ALARM. AFTER THE CHANGE IN MAY THE PATIENT STARTED EXPERIENCE ADVERSE EFFECTS, LIKE OVERDOSING. THE PATIENT WENT BACK TO THE PHYSICIAN IN (B)(6) JUST WANTING THE PUMP TO BE TURNED DOWN SLOWLY AND EVENTUALLY TAKEN OUT. PHYSICIAN NOTED THE PATIENT DEMANDED THE PUMP BE TURNED OFF. THE PHYSICIAN DECREASED THE MEDICATION BY 88% (MINIMUM FLOW RATE) UNTIL THE PATIENT WAS ABLE TO HAVE THE PUMP REMOVED AS DESIRED. THREE DAYS LATER THE PATIENT WAS GOING THROUGH WITHDRAWAL AND COULDN¿T SLEEP. THE PATIENT EXPERIENCED SYMPTOMS OF SWEATING, ANXIETY, TASTING AND SMELLING THE DRUG, NAUSEA, SENSATION OF ¿FREEZING¿, SHAKING, FLUSHING, AND ¿TERRIBLE¿ BOWEL MOVEMENTS. THE PUMP CONTAINED DILAUDID AT THE TIME OF THE EVENT.
CORRECTION - THE PATIENT HAD REPORTED IN (B)(6) 2012 THAT THAT THEY WERE GIVEN A PRINTOUT BY THEIR HEALTHCARE PROVIDER. THEY NOTED THEIR SHEET SAID ¿MOTOR STALL OCCURRED¿ AND THEY DID NOT HEAR THE ALARM. THE CAUSE OF THE STALL WAS NOT REPORTED, AND IT WAS NOT KNOWN IF IT RECOVERED.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT KNEW HER PUMP WAS ¿DEFECTIVE¿ FOR A ¿NUMBER OF REASONS¿. THE HEALTH CARE PROVIDER (HCP) REPORTEDLY DECEIVED HER AND KEPT HER DRUGGED AND LIED TO HER. AS REPORTED, IN (B)(6) 2012, THE PUMP ALARM SOUNDED BUT THE PATIENT NEVER HEARD IT. THAT WAS WHEN THE HCP THEN GAVE HER A BOLUS WITHOUT TELLING HER AND HE ¿KNEW THE PUMP WAS DEFECTIVE AT THAT POINT¿. THE PATIENT REPORTEDLY ALSO TOLD A DEVICE MANUFACTURER REPRESENTATIVE AT THAT POINT, IN (B)(6) 2012, ABOUT HER PUMP COMPLAINTS. A SPECIFIC DATE WAS NOT PROVIDED. THE PATIENT¿S BLOOD PRESSURE AT THAT TIME WAS IN ¿STROKE ZONE¿ BECAUSE SHE WAS BEING OVERDOSED. THE DEVICE MANUFACTURER REPRESENTATIVE RECOMMENDED EXPLANT AT THAT TIME. THE PATIENT THEN WENT TO SEE HER HCP IN (B)(6) 2012 AND HE LOWERED THE DOSE TO ¿0.18/DAY¿ AND THE PATIENT WENT FROM OVERDOSE TO WITHDRAWAL AND ¿ALMOST DIED¿. AS PREVIOUSLY REPORTED THE HCP PRESCRIBED HER PERCOCET THOUGH SHE DIDN¿T WANT TO TAKE IT. HE HAD ALSO WANTED TO PRESCRIBE OXYCONTIN/OXYCODONE BUT THE PATIENT NEVER TOOK THAT. WHEN THE PATIENT REFUSED TO TAKE OXYCONTIN THE HCP REPORTEDLY THREW HER OUT OF HIS OFFICE. IT WAS REPORTED THE HCP HATED THE PATIENT BECAUSE ¿HE¿S A FOREIGNER AND IN HIS COUNTRY WOMEN DON¿T SPEAK UP¿. AT THE TIME OF THIS REPORT THE DEVICE SYSTEM WAS REPORTEDLY USED TO DELIVER MORPHINE.
IT WAS LATER REPORTED THAT THE PATIENT HAD A DEFECTIVE PUMP. THE PATIENT¿S PREVIOUS HEALTH CARE PROFESSIONAL (HCP) DISMISSED THE PATIENT FROM THEIR PRACTICE. IT WAS NOTED THAT THE PATIENT FOUND ANOTHER HCP THAT WAS WILLING TO REMOVE THE PUMP; HOWEVER THE HCP WOULD NOT TURN THE PUMP OFF. THE PATIENT BELIEVED THE PUMP WAS EMPTY AND HADN¿T HAD ANY ADJUSTMENT IN 2 YEARS. THE PATIENT¿S PUMP WAS PREVIOUSLY SET TO MINIMAL DOSE AND WAS SUPPOSED TO LAST UNTIL 2016 HOWEVER, THE PATIENT SAID THAT WAS NOT TRUE. THE PATIENT HAD AN APPOINTMENT WITH THEIR HCP THE FOLLOWING WEEK AND ¿NEEDS OFF BEFORE.¿ THE PATIENT¿S HCP REPORTEDLY WANTS CONFIRMATION THE PUMP IS OFF AT THE TIME OF REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP WAS REMOVED THE PRIOR FRIDAY. IT WAS NOTED THAT THE PUMP WAS EMPTY AND IT DID NOT ALARM. THE PATIENT REPORTED THAT THE PRIOR HCP TOLD THEM THAT THERE WAS DILAUDID IN THE PUMP UNTIL 2016. AS PREVIOUSLY REPORTED, THE PATIENT MENTIONED THAT IN 2012 THE HCO INCREASED THEIR DILAUDID WHEN SHE HAD SURGERY FOR A ¿FEMALE ISSUE¿. IT WAS NOTED THAT THE MORPHINE THAT GAVE HER CAUSED THE PATIENT TO OVERDOSE BECAUSE THE PATIENT DID NOT KNOW ABOUT THE DOSAGE INCREASE. THEN IN 2012, AS PREVIOUSLY REPORTED THAT PATIENT¿S HCP REDUCED THEIR DOSAGE TO LOWEST SETTING AND THE PATIENT WENT INTO WITHDRAWAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306451 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00055 YR | Other |