SYNCHROMED II
Report
- Report Number
- 3004209178-2013-06380
- Event Type
- Injury
- Date Received
- April 16, 2013
- Date of Event
- January 1, 2011
- Report Date
- November 22, 2016
- 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
- KY, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4) NO LONGER APPLIES TO THE PUMP. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT ID: 8709 SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE CATHETER. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP HAD COME LOOSE BECAUSE THE PATIENT LOST HIS FOOT. IT WAS NOTED THE PUMP HAD BEEN LOOSE INSIDE THE PATIENT ¿FOR A WHILE¿.
IT WAS REPORTED THAT RIGHT AROUND THE TIME THE SECOND PUMP HAD BEEN IMPLANTED ON (B)(6) 2012, IT BECAME LOOSE AND HAD TO BE REVISED AND THEN LATER BECAME LOOSE AGAIN. THE PATIENT STATED, IT COME LOOSE AND "HE WENT BACK IN THERE AND FIXED IT, AND NOW THEN IT'S PARTIAL LOOSE AGAIN". IN ADDITION, THE PATIENT STATED "AND IT'S A HURTING ME LIKE I DON'T KNOW WHAT". THE REPORTER WAS UNSURE OF THE TIMELINE OR WHEN THE EVENT TOOK PLACE; HOWEVER, IT WAS AROUND THE TIME THAT THE PUMP WAS REPLACED. APPROXIMATELY A YEAR AGO, WHEN THE PUMP BECAME LOOSE AGAIN, THE PATIENT SPOKE TO THE HEALTHCARE PROVIDER ABOUT IT, AND HE NOTED THE PATIENT SHOULD NOT WORRY ABOUT IT. THE PATIENT INDICATED THAT SOMETHING NOW NEEDED TO BE DONE, AS IT "BOTHERS ME FROM EATING", "UPSETS MY STOMACH", AND "IT HURTS ME ALL THE WAY AROUND", "ALL THE WAY ACROSS ON THE RIGHT SIDE". IT WAS THEN NOTED, IT WAS HURTING THE PATIENT ON THE LEFT SIDE AS WELL. THE PATIENT STATED "IT BOUNCES OVER THERE AND HURTS". IT WAS NOTED THAT IT DID NOT HURT "ALL THE TIME". THE PAIN WAS DESCRIBED "LIKE A CUTTING" AND HAD BEEN GOING ON FOR 7 OR 8 MONTHS, AND THE PUMP WAS "TURNED ON ITS SIDE". THE LAST TIME THE PATIENT SAW THE HCP, "IT WAS TURNED PART OF THE WAY". THE PATIENT CALLED THE HCP A WEEK PRIOR TO THE REPORT DATE, BUT NOT YET BEEN ABLE TO GET IN CONTACT WITH THE HCP. THE PATIENT WAS PLANNING TO CONTACT THE HCP AGAIN TO DISCUSS THE EVENT. IT WAS LATER REPORTED ON (B)(6) 2013, "WHEN THE PUMP IN, I SEEN A SCORCHED PLACE, BURNT LIKE PLACE WHEN THEY PUT IT IN", "LIKE IRONING OR SOMETHING", "THAT'S ABOUT WHAT IT LOOKED LIKE". WHEN FURTHER CLARIFICATION WAS REQUESTED, THE REPORTER WAS UNABLE TO PROVIDE INFORMATION. IT WAS THEN REITERATED THAT THE "PUMP COME LOOSE" AND THE HCP DID NOT SEEM CONCERNED, AND THAT "IT'S BEEN HURTING". THE PATIENT INDICATED SEEING THE HCP ON EITHER THE FRIDAY OR THE MONDAY PRIOR TO THE LATER REPORT DATE. THE PATIENT THEN NOTED BEING IN THE HOSPITAL FOR FOUR DAYS, AND INITIALLY INDICATED, IT WAS FOR AN UNRELATED REASON; HOWEVER, LATER STATED "I WAS IN THERE FOUR DAYS AND THEY CHECKED ME OUT, XRAYED ME, EVERY WHERE". THE INFORMATION REPORTED MADE IT UNCLEAR WHAT THE CAUSE OF THE HOSPITALIZATION WAS. THE PATIENT NOTED DISSATISFACTION WITH THE HCP, AS THE INFORMATION HAD BEEN RELAYED TO THE HCP TWICE ALREADY. THE REPORTER INDICATED IT WAS DIFFICULT TO RECALL EVENTS AND WAS UNABLE TO PROVIDE FURTHER DETAIL. THE INFORMATION PROVIDED MADE THE EVENTS AND TIMELINES UNCLEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED ON 2016-NOV-21 STATED THE MEDICATION IN THE PUMP WAS MORPHINE WITH AN UNKNOWN DOSE AND CONCENTRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 163718 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization| R |