FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3142657
·
Received June 3, 2013
Report
- Report Number
- 3004209178-2013-08543
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Report Date
- May 9, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 8709, LOT# L62602, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A ¿FLOATING PUMP¿. IT WAS STATED THAT THE IMPLANTING PHYSICIAN HAD A LOT OF TROUBLE GETTING IT ¿ATTACHED TO HER PERENNIAL¿ AND HAD TO GRASP AT SOMETHING TO ATTACH IT TO. THERE WAS ¿A LOT OF TROUBLE¿ ANYTIME IT NEEDED TO BE ASPIRATED OR REFILLED. IT WAS REPORTED THAT THE PUMP CONTAINED MORPHINE FOR THE 20 YEARS PRIOR TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244024 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |