SYNCHROMED II
Report
- Report Number
- 3004209178-2014-10215
- Event Type
- Injury
- Date Received
- June 5, 2014
- Date of Event
- May 18, 2014
- Report Date
- May 18, 2014
- 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
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT PRODUCT: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER. (B)(4).
(B)(4).
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).
ANALYSIS OF THE 8780 CATHETER/SC CONNECTOR REVEALED A POSSIBLE POOR CONNECTION TO THE PUMP CAUSING LEAK OR DETACHMENT. NO ANOMALIES WERE SEEN INSIDE THE SC CONNECTOR. ANALYSIS OF THE PUMP FOUND NO ANOMALY. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SPASMS THE PATIENT EXPERIENCED INCLUDED BACK SPASMS. THE PREVIOUSLY REPORTED "KIDNEYS STARTED TO SHUT DOWN" WAS FURTHER REPORTED AS KIDNEY FAILURE.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP AND THE PUMP SEGMENT OF THE CATHETER WERE EXPLANTED ON (B)(6) 2014 AND REPLACED. IT WAS FURTHER REPORTED ON (B)(6) 2014 THE CATHETER WAS REVISED BECAUSE THE PATIENT EXPERIENCED A LACK OF THERAPY AND INCREASED SPASTICITY. IT WAS NOTED THE DOCTORS DECIDED NOT TO REPLACE THE PUMP AS IT WAS ONLY 7 MONTHS OLD; HOWEVER THE NEXT DAY THE PATIENT WAS STILL NOT IMPROVING SO A DYE STUDY WAS ORDERED FOR (B)(6) 2014. THE DYE STUDY SHOWED THE POCKET FILLED WITH DYE AND A ROTOR STUDY SHOWED THE PUMP WORKING NORMAL. IT WAS REPORTED THE PATIENT WENT TO SURGERY TO IDENTIFY WHY THE POCKET WAS GETTING FULL AND WHEN THE POCKET WAS OPENED IT WAS SEEN THAT THE PUMP CONNECTOR HAD DISCONNECTED FROM THE PUMP. THE PUMP SEGMENT WAS REPLACED AND THE PUMP ALSO, AS THEY COULD NOT DETERMINE WHY IT WOULD HAVE DISCONNECTED. IT WAS NOTED THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.
THIS EVENT WAS ALSO REPORTED UNDER MANUFACTURER REPORT # 3004209178-2014-11306 . [IT WAS FURTHER REPORTED THE PATIENT RECENTLY HAD A CATHETER REVISION {REFER TO MANUFACTURER REPORT # 3004209178-2014-10215} AND WAS GETTING GOOD THERAPY, BUT NOW WAS NOT. A DYE STUDY WAS PERFORMED AND THE HEALTHCARE PROVIDER (HCP) SAW DYE IN THE PATIENT'S POCKET WHERE THE PUMP IS. IT WAS NOTED THE HCP WAS CONCERNED ABOUT A CATHETER DISCONNECT. A (B)(6) STUDY WAS GOING TO BE PERFORMED ON (B)(6) 2014. IT WAS ALSO REPORTED THERE WERE NO STALLS WHEN THE PUMP WAS INTERROGATED. THE PUMP WAS BEING USED TO DELIVER GABLOFEN]. ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED UNDER THIS MANUFACTURER REPORT NUMBER# (3004209178-2014-10215). ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS DISCOVERED DURING THE DYE STUDY THAT THE DYE WAS FILLING THE POCKET. IT WAS NOTED THE PATIENT WAS SENT TO SURGERY AND IT WAS DISCOVERED THAT THE PUMP CONNECTOR HAD DETACHED FROM THE PUMP. DURING THE DYE STUDY UNDER FLUOROSCOPY (FLUORO) IT LOOKED TO BE STILL ATTACHED TO THE PUMP; HOWEVER WHEN THE DOCTOR OPENED THE POCKET IT WAS DETACHED. THE REASON FOR IT "UNCOUPLING" FROM THE PUMP WAS UNKNOWN AND THEREFORE THE DOCTOR ELECTED TO REVISE THE PUMP SEGMENT AND PUMP AND SEND THEM BACK FOR ANALYSIS. IT WAS FURTHER REPORTED DURING IMPLANT IT WAS ATTACHED, ROTATED AND TUGGED WITH NO ISSUES. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT EXPERIENCED AN UNDERDOSE. IT WAS NOTED AT THE END OF (B)(6) THE PATIENT STARTED FEELING VIBRATION AT THE SITE OF HER PUMP AND THE PATIENT CALLED HER DOCTOR AND WENT TO SEE HIM THE NEXT DAY. THE HEALTHCARE PROVIDER (HCP) INTERROGATED THE PUMP AND SAW NO ISSUES, AND SENT THE PATIENT HOME EVEN THOUGH SHE STARTED EXHIBITING SYMPTOMS OF WITHDRAWAL SUCH AS ITCHING AND RETURN OF SPASMS. THE PATIENT DROVE HOME AND RIGHT BEFORE SHE GOT HOME THE DOCTOR CALLED HER AND SUGGESTED SHE GO TO HAVE THE PUMP CHECKED IN (B)(6), BUT IT WAS UNKNOWN WHAT MADE THE PHYSICIAN CHANGE HIS MIND. THE PATIENT HAD AN "UNEASY FEELING" AND SHE DROVE TO (B)(6). IT WAS NOTED BY THE TIME SHE GOT THERE SHE WAS IN COMPLETE BACLOFEN WITHDRAWAL AND HAD A LOT OF ITCHING AND SPASMS. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND "HER KIDNEYS SHUT DOWN" AND "THEY ALMOST LOST ME TWICE." IT WAS ALSO REPORTED THE CATHETER WAS X-RAYED AND IT SHOWED "A KNOT IN THE TUBING" THAT WAS ADHERED TO THE SPINE. A CATHETER REVISION WAS COMPLETED AND THEN THE NEXT DAY THEY REPLACED THE PUMP. IT WAS REPORTED THE PUMP "COMPLETELY MALFUNCTIONED," BUT SHE DID NOT KNOW WHAT WAS SEEN IN TERMS OF THE LOGS OF THE PUMP. THE PATIENT STATED SHE MAY WANT TO FIND A NEW PHYSICIAN. NO ALARMS WERE HEARD FROM THE PUMP. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT EXPERIENCED A CHANGE IN THERAPY EFFECT. IT WAS NOTED IN (B)(6) 2014 THE ¿TUBING ADHERED TO ME¿ AND THE PATIENT WENT THROUGH WITHDRAWAL. IT WAS CLARIFIED THE CATHETER HAD ADHERED TO HER BODY, BUT THE LOCATION OF THE ADHESION COULD NOT BE SPECIFIED. IT WAS FURTHER REPORTED THE WITHDRAWAL CAUSED ¿MAJOR ORGAN SHUT DOWN¿ INCLUDING SHUTTING DOWN HER KIDNEYS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
IT WAS REPORTED THE HEALTHCARE PROVIDER (HCP) FELT LIKE THE PATIENT¿S PUMP WAS VIBRATING EVERY TEN MINUTES AND IT STARTED TO HAPPEN EARLIER ON THE EVENING OF THIS REPORT. IT WAS NOTED THE PATIENT DID NOT HAVE ANY WITHDRAWAL. IT WAS FURTHER REPORTED THE HCP WAS AT HOME AND WAS NOT WITH THE PATIENT AT THIS TIME. HE WAS TO CONTINUE MONITORING HER FOR SYMPTOMS AND SEE HER ON (B)(6) 2014 IN THE MORNING IF NOT SOONER. THE PATIENT GETS REFILLED EVERY SIX MONTHS AND WAS DUE FOR A REFILL NEXT WEEK. THE PUMP WAS BEING USED TO DELIVER BACLOFEN. IT WAS FURTHER REPORTED THE PATIENT EXPERIENCED INCREASED SPASTICITY. IT WAS NOTED THE PUMP WAS IMPLANTED IN (B)(6) 2013. IT WAS ALSO REPORTED THE NIGHT OF (B)(6) 2014 THE PATIENT COULD FEEL A VIBRATION FROM HER PUMP, BUT SHE WAS NOT HEARING ANY ALARMS AND THE PATIENT HAS HAD AN INCREASE IN SPASTICITY OVERNIGHT. IT WAS FURTHER REPORTED ON (B)(6) 2014 THE PATIENT HAD THE PUMP INTERROGATED AND SHE WAS TOLD THE PUMP WAS WORKING FINE. IT WAS NOTED THE VIBRATION GOES AWAY AND THEN IT COMES BACK AND THE PATIENT WAS NOT FEELING IT CURRENTLY. IT WAS REPORTED, ¿IT DID NOT STALL OUT.¿ ADDITIONAL INFORMATION RECEIVED REPORTED BREAKTHROUGH RIGIDITY, DISCOMFORT, AND UNDERDOSE. IT WAS REPORTED A REVISION OF THE CATHETER WAS HAPPENING ON (B)(6) 2014 BECAUSE THE CATHETER WAS NOT PATENT. THE HCP WAS UNABLE TO GET ANY CEREBROSPINAL FLUID (CSF) BACKFLOW AND THE DOCTOR WAS QUESTIONING IF THE PUMP SHOULD BE REPLACED AT THE SAME TIME AS THE CATHETER REVISION ON THE DATE OF THIS REPORT. CURRENT PUMP ELECTIVE REPLACEMENT INDICATOR (ERI) READ 74 MONTHS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329763 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR | Hospitalization| R |