FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1040274
·
Received May 8, 2008
Report
- Report Number
- 3004209178-2008-02489
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- April 9, 2008
- Report Date
- April 9, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE NURSE INCREASED PT'S DAILY DOSE FROM 31.9 MG/DAY TO 35 MG/DAY. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED, DEVICE REGISTRATION INDICATES IT IS MORPHINE. PT WAS ADMITTED TO THE ER WITH UNSPECIFIED SYMPTOMS. THE ER HCP HAD REQUESTED INSTRUCTIONS FOR STOPPING THE PUMP. NO OUTCOME WAS REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM HCP, BUT WAS NOT AVAILABLE ON THE DATE OF THE REPORT.
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 | PROGRAMMER MODEL 8840 LOT#UNK| EXPLANTED| IMPLANTED| CATHETER MODEL 8709SC LOT# N112480021 |