SYNCHROMED II
Report
- Report Number
- 3004209178-2013-00117
- Event Type
- Injury
- Date Received
- January 3, 2013
- Date of Event
- November 6, 2012
- Report Date
- March 27, 2018
- 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
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT ID 8780, LOT # 0205597378, PRODUCT TYPE CATHETER. (B)(4).
ANALYSIS OF THE PUMP REVEALED NO ANOMALIES. ANALYSIS OF THE CATHETER NOTED THE SUTURELESS CONNECTOR HAD A TEAR IN THE SEAL NEAR THE GUIDE RING.
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, LOT# 0205597378, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER; PRODUCT ID 8780, LOT# 0205597378, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER.
(B)(4).
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
CORRECTED INFORMATION: NO EVAL EXPLAIN CODE 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.
IT WAS REPORTED THAT THE PATIENT EXHIBITED SWELLING OVER THE REFILL SEPTUM AREA OF THE PUMP FOLLOWING A REFILL. THE PATIENT PROCEEDED HOME, BUT RETURNED THAT EVENING WITH SEVERE WITHDRAWAL SYMPTOMS. IT WAS REPORTED THAT, TWO DAYS LATER, THERE WERE NO VOLUME DISCREPANCIES OF THE DRUG RESERVOIR, CEREBROSPINAL FLUID (CSF) WAS SUCCESSFULLY ASPIRATED FROM THE CATHETER ACCESS PORT (CAP), AND THE PHYSICIAN CONFIRMED THE CONCENTRATION OF THE DRUG WAS CORRECT. A ROTOR TEST WAS SCHEDULED FOR THE PATIENT'S NEXT REFILL ON (B)(6). THE PATIENT'S OUTCOME STATED HE WAS IN A "BAD GENERAL STATE" AND HAD A "RECURRENCE OF SPASTICITY." THE DRUG BEING USED IN THIS SYSTEM WAS BACLOFEN. 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 LATER REPORTED THAT ALL THE OCCURRENCES OF WITHDRAWAL WERE A COUPLE DAYS AFTER REFILL. IT WAS NOTED THAT EACH FILLING WAS MADE IN THE SAME WAY AND LIORESAL WAS USED WITHOUT MIXING AT 10MG/ 5ML. IT WAS REPORTED THAT NO MOTOR STALL OCCURRED. IT WAS NOTED THAT THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT¿S HEALTHCARE PROVIDER DECIDED TO REPLACE THE ENTIRE SYSTEM INCLUDING THE PUMP AND CATHETER TO REMOVE ANY MATERIAL CAUSE.
IT WAS FURTHER REPORTED THAT THE DOCTOR DID A TEST OF ROTATION OF THE PUMP AND AN OPACIFICATION OF THE CATHETER. THESE TESTS SHOWED NOTHING ABNORMAL. WITHOUT TECHNICAL EXPLANATION, THE LIORESAL DOSES WERE REDUCED AND THEN GRADUALLY INCREASED AGAIN. THE CHILD EXPERIENCED A SECOND WITHDRAWAL, LIGHTER THAN THE FIRST TIME, AT END OF AUGUST. THIS OCCURRED A FEW DAYS AFTER FILLING. ON (B)(6), THE YOUNG PATIENT EXPERIENCED ANOTHER MAJOR WITHDRAWAL A FEW DAYS AFTER FILLING. THE PHYSICIAN REPLACED THE CATHETER (B)(6) 2013. AT THAT TIME FIBROSIS WAS NOTED WHICH HAD PENETRATED INTO THE CONNECTOR AT THE PUMP. THE PHYSICIAN QUESTIONED WHY THE PATIENT HAD ISSUES A FEW DAYS AFTER FILLING THE PUMP AND HAD ALSO THOUGHT OF A MISALIGNMENT OF THE CONNECTOR. THIS PHYSICIAN REPORTEDLY EXERTED PRESSURE ON THE TOP OF THE PUMP TO POSITION THE TEMPLATE ON THE PUMP CORRECTLY WHEN FILLING. THE PHYSICIAN WONDERED IF THIS PRESSURE, PARTLY AT THE CONNECTOR, COULD INCREASE MISALIGNMENT OF THE CONNECTOR AND HINDER THE WAY OF THE DRUG. IT WAS FURTHER REPORTED THAT THERE WERE NO DRUG RESERVOIR VOLUME DISCREPANCIES AND THE EXPLANTED CATHETER WAS DISPOSED AND WILL NOT BE RETURNED. FURTHER, TWO DAYS AFTER THE CHANGE OF THE PUMP SEGMENT OF THE CATHETER THE PATIENT EXPERIENCED A SLIGHT WITHDRAWAL AGAIN. THE RELATIONSHIP BETWEEN THE PATIENT¿S FAMILY AND PHYSICIAN BECAME ¿DIFFICULT.¿ THE FAMILY REPORTEDLY TOOK ADVICE FROM ANOTHER PHYSICIAN. IT WAS THEN FURTHER REPORTED FROM THAT PHYSICIAN THAT THE PATIENT MADE SEVERAL ¿DETOXIFICATION FOLLOWING WHAT "GUUS" REPLACED CONNECTING THE CATHETER ASCENDA THERE 10 DAYS. THE CATHETER HAD DISLODGED PREVIOUS ASCENDA PUMP AT THE CONNECTION AND FOUND FIBROSIS BETWEEN THE CATHETER AND PUMP ...SO HE JUST RECONNECTED AND IT WORKED FOR 2 DAYS THEN WEANING. FURTHER, ALL FLUOROSCOPY WAS REVIEWED; C2 CATHETER , SUCTION LCR OK EASY, 2-3 CC OMNIPAQUE INJECTION NO LEAKS, EVEN MOBILIZED THE PUMP WITHOUT SHOWING LEAKAGE.¿ HOWEVER, ¿ AFTER ASPIRATED 1.5 CC LCR THROUGH THE SIDE PORT, AND INJECTION OF 2-3 CC OMNIPAQUE , THE PATIENT DID OVERDOSE BACLOFENE WHO FINALLY LED TO THE ICU FOR MONITORING OVERDOSE.¿ FURTHER THE FAMILY HAD READ ON THE INTERNET REGARDING A GENERAL RECALL FOR FAILURE OF CONNECTIONS INDURATION. THE FAMILY HAD QUESTIONED ANOTHER OPERATION AND WHAT WOULD BE CHANGED, THE ENTIRE SYSTEM VERSES THE CATHETER AND/OR PUMP, AS IT STATED THAT IT COULD BE A PUMP PROBLEM. HOWEVER, REPORTEDLY, THE PATIENT WAS NOT IMPLANTED WITH MODELS RELATED TO THIS RECALL. AGAIN IT WAS REPORTED THAT THE REMAINING VOLUMES APPEARED TO CORRESPOND TO THE MEASURED VOLUMES.
ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE MANUFACTURER'S REFILL KIT WAS USED FOR THE REFILL PROCEDURE. IT WAS REPORTED THE PATIENT WAS NOT STILL IN THE HOSPITAL. IT WAS UNCLEAR WHETHER THE PATIENT WAS ACTUALLY HOSPITALIZED. THE REPORTER NOTED THERE WERE NO MESSAGES STORED UPON PUMP INTERROGATION. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL.
ADDITIONAL INFORMATION RECEIVED REPORTED ON (B)(6) 2013 THERE WAS A REVISION OF THE CATHETER BECAUSE THE PATIENT HAD SYMPTOMS OF UNDERDOSE SUCH AS ITCHING AND INCREASED SPASTICITY. AGAIN ON (B)(6) 2013 THE PATIENT HAD SIGNS OF UNDERDOSE, THE DIAGNOSIS OF THE CATHETER WAS NORMAL, AND A CONTRAST STUDY WAS PERFORMED AFTER THERE WERE SYMPTOMS OF OVERDOSE (THEY THOUGHT THE REASON FOR THIS ISSUE WAS AIR IN THE CATHETER). DUE TO ALL OF THESE PROBLEMS THE NEUROSURGEON DECIDED TO EXPLANT THE CATHETER AND THE PUMP ON (B)(6) 2014 AND IMPLANT A NEW PUMP AND CATHETER. THE DATE OF SYSTEM EXPLANT/REPLACEMENT WAS DISCREPANT AS THE EXPLANT DATE PREVIOUSLY REPORTED WAS (B)(6) 2014. IT WAS NOTED UNTIL TODAY THE PATIENT FELT FINE AND THERE WERE NO SYMPTOMS OF UNDER OR OVERDOSE. ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED EXPLANT, REPLACEMENT, AND REPROGRAMMING. IT WAS ALSO REPORTED X-RAYS WERE PERFORMED, BUT THE CAUSE OF THE ISSUE WAS UNDETERMINED. THE SYMPTOMS REPORTED WAS "FIRST UNDERDOSE AND AFTER A DYE STUDY OVERDOSE" INCREASED SPASTICITY, UNDERDOSE AND OVERDOSE SYMPTOMS, AND ITCHING. THE PATIENT'S STATUS AT THE TIME OF THIS REPORT WAS "ALIVE- NO INJURY." ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3101 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00010 YR | Other| R |