FDA Adverse Event
Other
Summary report: N
SYNCHROMED EL
MDR report key: 480174
·
Received August 19, 2003
Report
- Report Number
- 6000030-2003-00740
- Event Type
- Other
- Date Received
- August 19, 2003
- Date of Event
- July 29, 2003
- Report Date
- August 15, 2003
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE HCP EXPLANTED AND REPLACED THE PUMP AND RETURNED IT TO THE MANUFACTURER FOR ANALYSIS. THE PUMP IMPLANT DURATION WAS 38 MONTHS. 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 | 17 YR | Other | CATHETER MODEL #8709, LOT L78417| IMPLANTED: 2003, EXPLANTED: UNK. |