FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1900506
·
Received October 28, 2010
Report
- Report Number
- 3004209178-2010-08606
- Event Type
- Malfunction
- Date Received
- October 28, 2010
- Date of Event
- September 1, 2010
- Report Date
- October 4, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE HEALTH CARE PROFESSIONAL REPORTED THAT THE PT'S PUMP HAD FLIPPED. THE PT ALSO SUFFERED A FALL. THE HCP FLIPPED THE PUMP BACK AND REFILLED IT. THE PT WAS BEING MONITORED AND WAS "DOING WELL." NO PT SYMPTOMS WERE REPORTED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS MORPHINE AT 3.2 MG/DAY. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP 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 | 81 YR | CATHETER: MODEL 8709, LOT# J11702R18| IMPLANTED:| EXPLANTED: |