FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3813005
·
Received May 15, 2014
Report
- Report Number
- 3004209178-2014-09025
- Event Type
- Malfunction
- Date Received
- May 15, 2014
- Report Date
- April 21, 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
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS:PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(4) 2012, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT¿S PUMP HAD MOVED SINCE LAST YEAR, SPECIFIED AS THE END OF THE SUMMER. IT WAS NOTED THAT THE PATIENT¿S HEALTHCARE PROVIDER (HCP) HAD A HARD TIME FINDING THE PORT. IT WAS REPORTED THAT IT HAD BEEN PAINFUL TO GET REFILLS, ¿IF HURTS LIKE HELL¿. IT WAS NOTED THAT IT DIDN¿T HURT PRIOR AND NOW THE PATIENT HAD TO TAKE VALIUM WHEN GOING FOR A REFILL. IT WAS REPORTED THAT THE PUMP IS CLOSER TO THE SKIN SURFACE AT THE TIME OF REPORT. IT WAS NOTED THAT THE PATIENT HAD GAINED SOME WEIGHT SINCE THEIR IMPLANT. IT WAS REPORTED THAT THE PATIENT¿S PUMP WAS USED TO INFUSE FENTANYL, BUPIVACAINE AND DILAUDID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290843 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR |