FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1992891
·
Received February 4, 2011
Report
- Report Number
- 3004209178-2011-00874
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 11, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT FELL ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PUMP WAS "TICKING/CLICKING AND IS NOT WORKING". THE PT PRESENTED TO THE ER. THE HCP PLANNED TO LISTEN TO THE PUMP AND CHECK WITH THE PT TO SEE IF SHE CAN STILL HEAR IT TICKING. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8703W, LOT# L36765| CATHETER: MODEL 8703W, LOT# L54372 |