FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1990801
·
Received February 8, 2011
Report
- Report Number
- 3004209178-2011-00955
- Event Type
- Injury
- Date Received
- February 8, 2011
- Date of Event
- November 1, 2009
- Report Date
- February 4, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT WENT INTO WITHDRAWAL. THE PUMP WAS FOUND TO BE EMPTY PRIOR TO THE SCHEDULED REFILL. THE PUMP WAS REPLACED. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. A FOLLOW UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11609R51| IMPLANTABLE INFUSION PUMP: MODEL 863740| EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8578, LOT# N147409| IMPLANTED:| LOT# NGV429933H |