FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2023468
·
Received March 8, 2011
Report
- Report Number
- 3004209178-2011-01723
- Event Type
- Malfunction
- Date Received
- March 8, 2011
- Date of Event
- February 26, 2011
- Report Date
- February 28, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT HEARD THE PUMP ALARMING. TELEMETRY CONFIRMED A CLINICAL ALARM WAS OCCURRING. THE ALARM WAS DUE TO A MOTOR STALL; THE STALL WAS CONSTANT. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID, CLONIDINE, AND BUPIVACAINE. ADDITIONAL INFO HAS BEEN REQUESTED. 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 | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | CATHETER: MODEL 8578, LOT# N084002| CATHETER: MODEL 8709, LOT# L54769| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: |