FDA Adverse Event
Other
Summary report: N
SYNCHROMED EL
MDR report key: 485502
·
Received September 23, 2003
Report
- Report Number
- 6000030-2003-00868
- Event Type
- Other
- Date Received
- September 23, 2003
- Report Date
- September 17, 2003
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE HCP REPORTED THE PUMP WAS REMOVED DUE TO AN INFECTION. 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 MFG | 862718 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other | CATHETER MODEL 8711 LOT# J11460R70 IMPLANTED: 2003| EXPLANTED:UNK. |