FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1082478
·
Received July 25, 2008
Report
- Report Number
- 3004209178-2008-04408
- Event Type
- Injury
- Date Received
- July 25, 2008
- Date of Event
- January 1, 2007
- Report Date
- June 26, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS FOUND TO BE UPSIDE DOWN AT THE TIME OF THE FIRST REFILL; CONFIRMED WITH FLUOROSCOPY GUIDANCE. THE PUMP CONTAINED MORPHINE SULFATE. THE PUMP WAS SURGICALLY REVISED. THE PATIENT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER MODEL 8709 LOT# N107433033| PROGRAMMER MODEL 8840 LOT# UNKNOWN| IMPLANTED:| EXPLANTED: |