SYNCHROMED II
Report
- Report Number
- 3004209178-2013-07951
- Event Type
- Injury
- Date Received
- May 21, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 26, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).
(B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS ¿SUPPOSEDLY¿ HAVING THE ENTIRE SYSTEM REPLACED. THE PATIENT HAD REPORTEDLY BEEN IN PAIN EVER SINCE THE PUMP FLOW STUDY WAS DONE AND HAD GONE THROUGH WITHDRAWALS ¿PROBABLY ABOUT THE TIME I WENT INTO THE HOSPITAL¿. WHILE THE PATIENT WAS IN THE HOSPITAL, ¿DEALING WITH THE PAIN¿ THE PATIENT HAD BEEN GIVEN IV DILAUDID TO ¿KEEP IT UNDER CONTROL¿. IT WAS REPORTED THE PATIENT HAD ALSO BEEN CONSTANTLY STIFF AND IT WAS NOTED ¿THIS WAS JUST GETTING PROGRESSIVELY WORSE AND WORSE¿. WHILE THE PATIENT WAS IN THE HOSPITAL, ¿ALL KINDS¿ OF BLOOD WORK WERE DONE AND ¿THEY COULDN¿T SEE ANYTHING THAT WOULD BE CAUSING YOU TO DO THAT. HE SAID THAT PRETTY MUCH LEAVES THE PUMP¿. AS OF THE DATE OF THIS REPORT THE PATIENT WAS STILL HAVING PROBLEMS. IT WAS NOTED HE HAD A HEADACHE ¿PRETTY MUCH¿ ALL THE TIME AND SPASMS. ¿ALL I HAVE TO DO IS MOVE FOR MY SPASMS TO KICK IN. I HAVE TO LAY LITERALLY AS STILL AS POSSIBLE TO KEEP MY SPASMS FROM KICKING IN. IT¿S PRETTY MUCH FULLY BODY¿. FOLLOWING THE DYE STUDY, THE HEALTH CARE PROVIDER (HCP) MADE THE RECOMMENDATION THAT THE ENTIRE SYSTEM SHOULD BE REPLACED DUE TO THE PUMP BEING IMPLANTED ¿COMING UP ON SIX FULL YEARS¿. THE PATIENT WAS THEN REFERRED TO A SURGEON HOWEVER THE PATIENT¿S HCP FAILED TO LET THE SURGEON KNOW ANYTHING ABOUT HIM, ¿YOU KNOW TREATING PAIN OR ANYTHING, BUT HE WAS NOT A PAIN MANAGEMENT DOCTOR¿. THE PATIENT¿S STATUS OF THE DATE OF THIS REPORT WAS ¿IN LIMBO¿ AND WAS WORKING WITH THE HCP¿S SCHEDULER. THE HCP HAD CHOSEN TO NOT PRESCRIBE ANY ORAL PAIN MEDICATIONS IN THE MEANTIME AND THE PATIENT WAS ¿PRETTY MUCH TO THE POINT¿ WHERE HE WAS READY TO GO TO THE EMERGENCY ROOM DUE TO BEING IN PAIN AND NOT GETTING ANY RELIEF. IT WAS NOTED A PUMP FLOW STUDY HAD BEEN DONE LAST YEAR AND AT THAT TIME IT HAD BEEN RECOMMENDED THAT THE CATHETER BE REPLACED THEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS PUMP MALFUNCTION OF ¿UNKNOWN¿ ISSUE. FAILURE TO ASPIRATE CATHETER AND ¿UNKNOWN LOCATION¿ OF CATHETER ISSUE. A DOSE ADJUSTMENT ON (B)(6) 2013, CATHETER DYE STUDY ON (B)(6) 2013, PUMP ROTOR STUDY ON (B)(6) 2013, NO RESULTS WERE REPORTED FOR THE INTERVENTIONS/TROUBLESHOOTING. PUMP AND CATHETER REVISION DONE, IT WAS UNKNOWN IF THE DEVICE WOULD BE RETURNED TO MANUFACTURER. IT WAS NOTED THAT THE ¿PATIENT REPORTED THAT THEY EXPERIENCED INCREASED SPASMS ALONG WITH SEIZURES.¿ OUTCOME NOTED AS RECOVERED WITHOUT SEQUELAE.
IT WAS LATER REPORTED THAT THE RESULTS OF THE ROTOR STUDY SHOWED THE ROTORS WERE FINE. THE CATHETER WAS REPLACED AND THE PUMP WAS REPLACED BECAUSE IT WAS REACHING END OF LIFE.
IT WAS REPORTED THAT A PATIENT PRESENTED TO A HOSPITAL WITH COMPLAINTS OF INCREASED PERIODIC, SHORT LIVED SPASMS IN THEIR ARMS AND ABDOMEN AS WELL AS SEIZURES. THE HEALTH CARE PROVIDER (HCP) AT THE HOSPITAL PLACED A CALL TO THE PATIENT¿S MANAGING HCP HOWEVER AFTER TWO HOURS THERE WAS STILL NO RETURN CALL. ON THE EVENING OF (B)(6) 2013, THE MANUFACTURER REPRESENTATIVE WENT TO THE HOSPITAL TO CHECK THE PATIENT¿S PUMP SETTINGS. IT WAS REPORTED THE PATIENT¿S REGISTERED NURSE EARLIER THAT DAY OBSERVED THE PATIENT HAVING A FIVE SECOND PERIOD OF WHAT WAS DESCRIBED AS UPPER BODY TWITCHING THAT RESEMBLED A SEIZURE. LATER THAT EVENING, THE PATIENT THEN REPORTEDLY SEEMED AT EASE AND RELAXED. IT WAS REPORTED THAT THE TWITCHING/SEIZURES HAD STARTED ¿ABOUT¿ TWO WEEKS AGO AND THAT IT INVOLVED THE PATIENT¿S WHOLE BODY. SOMETIMES THEY WERE BROUGHT ON BY POSITIONAL CHANGES IMMEDIATELY AFTER MOVING AND SOMETIMES THEY CAME OUT OF THE BLUE, SOMETIMES WHEN THE PATIENT TOUCHED THEIR LEGS. THE PATIENT REPORTEDLY HAD ALSO COMPLAINED OF BEING BLOATED. THE DEVICE SYSTEM WAS CHECKED AND THE PUMP LOGS SHOWED NO ALARMS. THE REPORTER WAS UNAWARE OF ANY VOLUME DISCREPANCIES THAT HAD OCCURRED AT REFILLS. THE HCP AT THE HOSPITAL REPORTEDLY HAD SEEN NO COGNITIVE ISSUES AND IT WAS NOTED THE PATIENT HAD BEEN NORMOTENSIVE AS WELL AS AFEBRILE. IT WAS REPORTED THAT NO ACTIONS REQUIRED AS A RESULT OF THE EVENT WERE REPORTED. AS OF THE DATE OF THIS REPORT, THE PATIENT STATUS WAS REPORTED TO BE ¿ALIVE ¿ WITH NO INJURY/ADVERSE EVENT¿. THE DEVICE SYSTEM WAS USED TODELIVER COMPOUNDED BACLOFEN AND MORPHINE. IT WAS LATER REPORTED THAT A FLOW STUDY WAS SCHEDULED FOR (B)(6) 2013. IT WAS LATER REPORTED A FLOW STUDY HAD BEEN ATTEMPTED ON (B)(6) 2013. THERE WAS NO SUCCESS IN ASPIRATING FLUID FROM THE CATHETER DESPITE MULTIPLE ATTEMPTS. IT WAS REPORTED THERE WERE NO OBVIOUS DISCONNECTIONS, FACTURES OR KINKS NOTED. NO ROTOR STUDY WAS DONE. THE FINDINGS WERE REPORTED TO THE PATIENT¿S MANAGING HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224437 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00044 YR | Hospitalization| R |