FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3142855
·
Received June 3, 2013
Report
- Report Number
- 3004209178-2013-08548
- Event Type
- Injury
- Date Received
- June 3, 2013
- Report Date
- May 7, 2013
- 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
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8703, LOT# J94133054, IMPLANTED: (B)(6) 1994, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT¿S PUMP WAS MOVING DUE TO SIGNIFICANT WEIGHT LOSS. IT WAS INDICATED THAT THE ¿CATHETER TUBING TO THE PUMP WAS TOO LONG¿ THE TUBING WAS ¿BUNCHING UP¿. IT WAS ADDED THAT THE HEALTHCARE PROVIDER (HCP) WANTED TO MOVE THE PUMP TO THE MIDDLE OF THE ABDOMEN; HOWEVER THE PATIENT DOES NOT BELIEVE ¿IT WAS A GOOD IDEA TO PUT IT THERE¿. NO PATIENT SYMPTOMS WERE REPORTED. NO PATIENT INJURY WAS REPORTED. THE PUMP WAS BEING USED TO DELIVER DILAUDID AND CLONIDINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243972 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |