FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 472723
·
Received July 18, 2003
Report
- Report Number
- 6000030-2003-00607
- Event Type
- Injury
- Date Received
- July 18, 2003
- Date of Event
- June 13, 2003
- Report Date
- June 17, 2003
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HCP REPORTED PT HAD RECEIVED "MORE MEDICATION THAN WANTED". PT WAS GETTING 1MG/DAY OF .5 MG/ML CONCENTRATION. THE PUMP WAS REFILLED IN 2003 WITH 25 MG/ML BUT THE PROGRAMMING WAS LEFT AT .5 MG/ML AND THE DAILY DOSE INCREASED TO 5 MG/DAY. THE PT THEN CALLED THE PHYSICIAN'S OFFICE WITH "MINOR OVERDOSE SYMPTOMS." THE PT RECEIVED ALL OF THE MEDICATION OVER TWO DAYS. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFO IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | PUMP | LKK | RICE CREEK MANUFACTURING | 862718 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other | EXPLANTED: UNK| IMPLANTED: 2003| LOT #B002148N15| CATHETER MODEL 8731 |