SYNCHROMED II
Report
- Report Number
- 3004209178-2012-08864
- Event Type
- Injury
- Date Received
- October 4, 2012
- Report Date
- September 12, 2012
- 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
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).
PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. PUMP AND CATHETER ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
(B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4).
IT WAS REPORTED THERE WAS A MOTOR STALL WITHOUT RECOVERY. THE PATIENT FELL ON (B)(6) 2012 AND THE ALARM ON HIS PUMP BEGAN TO SOUND SOMETIME AFTER THE FALL. THE PATIENT STATED THAT DUE TO THE FALL IT WAS FELT THAT HE 'BROKE THE PUMP.' THE PATIENT WAS SEEN BY THE HEALTHCARE PROVIDER (HCP) ON (B)(6) 2012 AND A MOTOR STALL OCCURRENCE WAS DISCOVERED. THE HCP WAS UNABLE TO REMOVE MOTOR STALL AFTER REPEATED INTERROGATION OF THE PUMP. PER THE PUMP LOGS, THE MOTOR STALL OCCURRED ON (B)(6) 2012 AT 0330 AND STILL HAD NOT RECOVERED BY (B)(6) 2012 0330, AS THE LOGS DISPLAYED 'STOPPED PUMP PERIOD MAY EXCEED TUBE SET' AT THAT TIME. THE PATIENT EXPERIENCED SYMPTOMS WHICH WERE DESCRIBED AS 'FEELING FLUID IN HIS ABDOMEN' AND 'FULLNESS.' PATIENT FURTHER DESCRIBED A FEELING 'LIKE IT WAS TRICKLING DOWN TO HIS LEGS,' AND A RETURN OF RESTLESS LEGS. THE PATIENT DECLINED ANY INTERVENTION AT THAT TIME AS IT WAS FELT THERE WAS NO ADEQUATE RELIEF SINCE BEING IMPLANTED. IT WAS LATER REPORTED THAT ACCORDING TO TELEMETRY THE PUMP WAS FULL. AS OF (B)(6) 2012, THE PUMP STILL HAD NOT RECOVERED FROM THE MOTOR STALL AND IT WAS UNKNOWN WHAT THE EXACT CAUSE OF THE STALL WAS. THE MEDICATIONS IN THE PUMP WERE HYDROMORPHONE, BUPIVACAINE AND BACLOFEN. PATIENT AND EVENT OUTCOME WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION: THE PATIENT HAD A KUB (KIDNEY, URETER, BLADDER), NOT KUV, X-RAY TO DETERMINE PUMP POSITION INSTEAD OF AN MRI.
ADDITIONAL INFORMATION INDICATED THAT THE PATIENT'S PUMP WAS EXPLANTED ALONG WITH PART OF THE CATHETER. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HAVING AN MRI ON (B)(6) 2012, WHICH HAD TO BE STOPPED BECAUSE THE PATIENT "FAILED" IT DUE TO NEEDING A "KUV" AND NOT BEING ABLE TO BE STILL LONG ENOUGH FOR THE SCAN, AS THE PATIENT WAS IN "SO MUCH PAIN". THE DETAILS OF THE PATIENT ISSUES AT THE TIME OF THE MRI WERE UNKNOWN TO THE REPORTER. IT WAS LATER REPORTED THAT THE PATIENT'S MOTOR STALL WHICH WAS ALREADY REPORTED, REMAINED STALLED PERMANENTLY. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR | Required Intervention |